Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 2:33 PM
Study NCT ID:
NCT02522767
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2015-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAE occurred in the time interval from initial dosing (IMP intake) to the end of trial visit, up to 8 weeks for the Mesalamine and Placebo Arms and an additional 8 weeks for the Open-Label extension period.', 'description': 'TEAEs were defined as AE which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 19, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 13, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mesalamine (Open-Label)', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 170, 'otherNumAffected': 8, 'seriousNumAtRisk': 170, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Faecal calprotectin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '0.73', 'ciUpperLimit': '3.32', 'pValueComment': 'The p-value was based on chi-square test without a continuity correction.', 'groupDescription': 'Proportions were compared between treatment groups, at a two-sided 0.05 significance level.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 8', 'description': "The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score.\n\nThe Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3.\n\nFurther, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised all randomized subjects.'}, {'type': 'SECONDARY', 'title': "Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 8', 'description': 'The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal \\[score=0\\], mild disease \\[score=1\\], moderate disease \\[score=2\\], severe disease \\[score=3\\]).\n\nThe statistical test was to be conducted only if the primary analysis was significant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Time to Cessation of Rectal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '30.0'}, {'value': '43.0', 'comment': 'Not estimable: Not estimable due to insufficient number of participants with cessation.', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 8', 'description': "Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary.\n\nThe statistical test was to be conducted only if the primary analysis was significant.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'The Proportion of Subjects With Endoscopic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '0.96', 'ciUpperLimit': '3.29', 'pValueComment': 'The p-value was based on chi-square test without a continuity correction.', 'groupDescription': 'Proportions were compared between treatment groups at a two-sided 0.05 significance level.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 8', 'description': 'Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised randomized subjects.'}, {'type': 'SECONDARY', 'title': 'The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.78', 'ciUpperLimit': '2.15', 'groupDescription': 'Proportions were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.', 'statisticalMethod': 'Generalized estimating equation approach', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 2, 4, and 8', 'description': 'Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis comprised all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Time to Normal Stool Pattern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'comment': 'Not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.02', 'pValueComment': 'The p-value was based on log-rank test.', 'estimateComment': 'Hazard ratio and its 95% CI were obtained from Cox proportional hazards model with treatment group as a factor.', 'groupDescription': 'Times to normal stool pattern were compared between treatment groups, at a two-sided 0.05 significance level.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 8', 'description': 'Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised randomized subjects.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.08', 'estimateComment': 'A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.', 'groupDescription': 'Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.', 'statisticalMethod': 'Repeated-measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 2, 4, and 8', 'description': 'Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised randomized subjects.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.60', 'spread': '13.52', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '19.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '16.52', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '16.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-2.01', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '22.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.39', 'ciLowerLimit': '-5.46', 'ciUpperLimit': '0.67', 'estimateComment': 'A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.', 'groupDescription': 'Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.', 'statisticalMethod': 'Repeated-measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 2, 4, and 8', 'description': 'The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprise all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Fecal Calprotectin Levels at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'categories': [{'measurements': [{'value': '-144.93', 'spread': '854.41', 'groupId': 'OG000'}, {'value': '-119.56', 'spread': '1083.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-289.69', 'ciLowerLimit': '-514.96', 'ciUpperLimit': '-64.42', 'estimateComment': 'An ANCOVA model was used to calculate estimates.', 'groupDescription': 'Changes from baseline were compared between treatment groups, at a two-sided 0.05 significance level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 8', 'description': 'The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented.', 'unitOfMeasure': 'ug/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Health Related Quality of Life (QoL) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '24.79', 'spread': '25.92', 'groupId': 'OG000'}, {'value': '18.75', 'spread': '33.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '33.58', 'spread': '29.69', 'groupId': 'OG000'}, {'value': '28.13', 'spread': '33.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '34.41', 'spread': '37.23', 'groupId': 'OG000'}, {'value': '24.73', 'spread': '36.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.80', 'ciLowerLimit': '5.10', 'ciUpperLimit': '20.50', 'estimateComment': 'A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimates.', 'groupDescription': 'Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.', 'statisticalMethod': 'Repeated-measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 2, 4, and 8', 'description': 'The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.\n\nThe adjusted changes from baseline and their differences between treatment groups are presented.\n\nThe IBDQ is an instrument used to assess quality of life in adult patients with UC.\n\nSubjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL).', 'unitOfMeasure': 'points on a score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set comprised randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}, {'id': 'OG002', 'title': 'Mesalamine (Open-Label)', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': "An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial.\n\nA 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product \\[IMP\\] intake) to the end of treatment visit.\n\nProportion of subjects with any TEAE (serious or non-serious) are presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Severity of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}, {'id': 'OG002', 'title': 'Mesalamine (Open-Label)', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subject With Abnormal Laboratory Values (Hematology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}, {'id': 'OG002', 'title': 'Mesalamine (Open-Label)', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}], 'classes': [{'title': 'Eosinophils/Leukocytes (%), Normal>=10 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Erythrocytes (10^6/uL), Low<=3.5 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Erythrocytes (10^6/uL), Normal<=3.5 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit (%), Low<=0.32 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit (%), Normal<=0.32 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit (%), Normal>=0.56 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin (g/dL), Low<=115 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin (g/dL), Normal<=115 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (10^3/uL), Normal <=2.8 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (10^3/uL), Normal >=16.0 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (10^3/uL), High >=16.0 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes/Leukocytes (%), Low<=10 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes/Leukocytes (%), Normal<=10 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes/Leukocytes (%), High>=80 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/Leukocyte (%), Normal<=15 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/Leukocyte (%), Normal>=90 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils/Leukocyte (%), High >=90 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Platelets (10^3/uL), High>=700 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented.\n\n\\>= greater than equal to; \\<= less than equal to.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Abnormal Laboratory Values (Coagulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}, {'id': 'OG002', 'title': 'Mesalamine (Open-Label)', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}], 'classes': [{'title': 'Prothrombin INR, Normal <0.8 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Prothrombin INR, Normal >1.1 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Prothrombin INR, High >1.1 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented.\n\nINR= International normalized ratio.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}, {'id': 'OG002', 'title': 'Mesalamine (Open-Label)', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}], 'classes': [{'title': 'ALT (U/L), Normal >3xULN to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST (U/L), Normal >3xULN to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST (U/L), High >3xULN to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin (mg/dL), Normal >=1.5xULN to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin (mg/dL), High >=1.5xULN to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'BUN (mg/dL), Normal >=10.7 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Calcium (mg/dL), Normal <=1.8 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Chloride (mmol/L), Normal >=115 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Chloride (mmol/L), High >=115 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'GGT (U/L), High >3xULN to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Glucose (mg/dL), Normal >=10 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose (mg/dL), High >=10 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium (mmol/L), Normal <=3.0 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Potassium (mmol/L), Normal >=5.8 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Potassium (mmol/L), High >=5.8 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Sodium (mmol/L), Low<=130 to Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented.\n\nALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 gram (g) extended release granules (sachet), administered orally once daily (QD)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}], 'periods': [{'title': 'Double-blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-label', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects provided their consent to receive additional 8 weeks open-label treatment with mesalamine.', 'groupId': 'FG000', 'numSubjects': '88'}, {'comment': 'Subjects provided their consent to receive additional 8 weeks open-label treatment with mesalamine.', 'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 71 sites in 10 countries (Bulgaria, Canada, Hungary, Latvia, Mexico, Russia, Serbia, Switzerland, Ukraine, and United States) recruited subjects to this trial between October 2015 to November 2017, the last subject completed last visit in April 2018.', 'preAssignmentDetails': 'A total of 411 subjects were screened, of which 228 subjects were randomized in a 1:1 ratio to either mesalamine or placebo group (114 subjects each), for 8 weeks double-blind treatment.\n\nSubjects who completed 8 weeks but failed to meet the defined criteria for remission received open-label treatment with mesalamine for additional 8 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mesalamine', 'description': 'Mesalamine 4 g extended release granules (sachet), administered orally QD'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo 4 g to match mesalamine extended release granules, administered orally QD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '13.09', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '13.68', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '13.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.68', 'spread': '4.546', 'groupId': 'BG000'}, {'value': '24.63', 'spread': '4.578', 'groupId': 'BG001'}, {'value': '24.66', 'spread': '4.552', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stool Frequency Score', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.81', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '0.78', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Stool Frequency Score is graded 0-3, where 0 is best.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rectal Bleeding Score', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.54', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '0.58', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '0.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Rectal Bleeding Score is graded 0-3, where 0 is best.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Endoscopic Response Score', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '0.47', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '0.48', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '0.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Endoscopic Response Score is graded 0-3, where 0 is best.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Intention-to-treat (ITT) analysis set comprised all randomized subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-11', 'size': 9724864, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-08T06:45', 'hasProtocol': True}, {'date': '2018-04-02', 'size': 401396, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-08T06:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2019-01-28', 'completionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2015-08-12', 'dispFirstSubmitQcDate': '2019-01-29', 'resultsFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2015-08-12', 'dispFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-19', 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With Remission', 'timeFrame': 'At Week 8', 'description': "The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score.\n\nThe Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3.\n\nFurther, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3)."}], 'secondaryOutcomes': [{'measure': "Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)", 'timeFrame': 'At Week 8', 'description': 'The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal \\[score=0\\], mild disease \\[score=1\\], moderate disease \\[score=2\\], severe disease \\[score=3\\]).\n\nThe statistical test was to be conducted only if the primary analysis was significant.'}, {'measure': 'Time to Cessation of Rectal Bleeding', 'timeFrame': 'Up to Week 8', 'description': "Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary.\n\nThe statistical test was to be conducted only if the primary analysis was significant."}, {'measure': 'The Proportion of Subjects With Endoscopic Improvement', 'timeFrame': 'At Week 8', 'description': 'Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8.'}, {'measure': 'The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8', 'timeFrame': 'At Week 2, 4, and 8', 'description': 'Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset.'}, {'measure': 'Time to Normal Stool Pattern', 'timeFrame': 'Up to Week 8', 'description': 'Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary.'}, {'measure': 'The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8', 'timeFrame': 'From baseline to Week 2, 4, and 8', 'description': 'Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best.'}, {'measure': 'The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8', 'timeFrame': 'From baseline to Week 2, 4, and 8', 'description': 'The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point.'}, {'measure': 'The Change From Baseline in Fecal Calprotectin Levels at Week 8', 'timeFrame': 'From baseline to Week 8', 'description': 'The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented.'}, {'measure': 'The Change From Baseline in Health Related Quality of Life (QoL) Scores', 'timeFrame': 'From baseline to Week 2, 4, and 8', 'description': 'The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.\n\nThe adjusted changes from baseline and their differences between treatment groups are presented.\n\nThe IBDQ is an instrument used to assess quality of life in adult patients with UC.\n\nSubjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL).'}, {'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'Up to Week 16', 'description': "An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial.\n\nA 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product \\[IMP\\] intake) to the end of treatment visit.\n\nProportion of subjects with any TEAE (serious or non-serious) are presented."}, {'measure': 'Severity of Adverse Events', 'timeFrame': 'Up to Week 16', 'description': 'The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.'}, {'measure': 'Proportion of Subject With Abnormal Laboratory Values (Hematology)', 'timeFrame': 'Up to Week 16', 'description': 'Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented.\n\n\\>= greater than equal to; \\<= less than equal to.'}, {'measure': 'Proportion of Subjects With Abnormal Laboratory Values (Coagulation)', 'timeFrame': 'Up to Week 16', 'description': 'Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented.\n\nINR= International normalized ratio.'}, {'measure': 'Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)', 'timeFrame': 'Up to Week 16', 'description': 'Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented.\n\nALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 18 to 75 years\n* Mild to moderate UC\n\nExclusion Criteria:\n\n* Disease limited to proctitis \\<15 cm\n* Short bowel syndrome\n* Prior colon resection surgery\n* History of severe/fulminant UC\n* Evidence of other forms of inflammatory bowel disease\n* Infectious disease (including human immunodeficiency virus \\[HIV\\], hepatitis B virus \\[HBV\\], or hepatitis C virus \\[HCV\\])\n* Intolerant or allergic to aspirin or salicylate derivatives\n* Use of rectal formulations (5-aminosalicylic acid \\[5-ASA\\], steroids) within ≤7 days\n* Women who are pregnant or nursing\n* History or known malignancy\n* History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial'}, 'identificationModule': {'nctId': 'NCT02522767', 'briefTitle': 'Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis', 'orgStudyIdInfo': {'id': '000174'}, 'secondaryIdInfos': [{'id': '2015-002557-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalamine', 'description': '4 g extended release granules (sachet)', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mesalamine', 'type': 'DRUG', 'otherNames': ['Mesalazine', 'Pentasa'], 'armGroupLabels': ['Mesalamine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'United Research Institute', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Associates of South Florida, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Palmetto Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'IMIC', 'geoPoint': {'lat': 25.62177, 'lon': -80.32477}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research Center of Florida', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Sweetwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Lenus Research and Medical Group', 'geoPoint': {'lat': 25.76343, 'lon': -80.37311}}, {'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials of SWLA, LLC', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cumberland Research Associates, LLC', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Gastroenterology Associates', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '37076', 'city': 'Hermitage', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Associates in Gastroenterology, PLC', 'geoPoint': {'lat': 36.19617, 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'Virginia', 'country': 'United States', 'facility': 'New River Valley Research Institute', 'geoPoint': {'lat': 37.12985, 'lon': -80.40894}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Digestive & Liver Disease Specialists', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital For Active Treatment Avis Medica', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Medical Center Excelsior OOD', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Medical Center-1-Sevlievo EOOD', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'City Clinic University Multiprofile Hospital for Active Treatment EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center 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