Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-01-20 @ 2:59 PM
Study NCT ID:
NCT02559206
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C523483', 'term': 'linaclotide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nomniewski@ironwoodpharma.com', 'phone': '(617) 621-8454', 'title': 'Nick Omniewski, MPH', 'organization': 'Ironwood Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 1, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 10, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Linaclotide DR1 30 μg', 'description': 'Linaclotide DR1 30 μg QD for 12 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 4, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Linaclotide DR1 100 μg', 'description': 'Linaclotide DR1 100 μg QD for 12 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 9, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Linaclotide DR1 300 μg', 'description': 'Linaclotide DR1 300 μg QD for 12 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 8, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Linaclotide DR2 30 μg', 'description': 'Linaclotide DR2 30 μg QD for 12 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Linaclotide DR2 100 μg', 'description': 'Linaclotide DR2 100 μg QD for 12 weeks', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 1, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Linaclotide DR2 300 μg', 'description': 'Linaclotide DR2 300 μg QD for 12 weeks', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 2, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 67, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks'}, {'id': 'OG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'OG002', 'title': 'Linaclotide DR1 30 μg', 'description': 'Linaclotide DR1 30 μg QD for 12 weeks'}, {'id': 'OG003', 'title': 'Linaclotide DR1 100 μg', 'description': 'Linaclotide DR1 100 μg QD for 12 weeks'}, {'id': 'OG004', 'title': 'Linaclotide DR1 300 μg', 'description': 'Linaclotide DR1 300 μg QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.370', 'spread': '0.241', 'groupId': 'OG000'}, {'value': '-1.938', 'spread': '0.241', 'groupId': 'OG001'}, {'value': '-1.667', 'spread': '0.234', 'groupId': 'OG002'}, {'value': '-1.656', 'spread': '0.240', 'groupId': 'OG003'}, {'value': '-2.140', 'spread': '0.236', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.569', 'ciLowerLimit': '-1.214', 'ciUpperLimit': '0.076', 'statisticalMethod': 'mixed model repeated measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3661', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.297', 'ciLowerLimit': '-0.942', 'ciUpperLimit': '0.348', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3869', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.286', 'ciLowerLimit': '-0.936', 'ciUpperLimit': '0.363', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0199', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.771', 'ciLowerLimit': '-1.419', 'ciUpperLimit': '-0.123', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0276', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Trend test performed using linear contrast statement for each DR formulation with placebo.', 'statisticalMethod': 'Trend Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to Week 12', 'description': 'Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant\'s weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks'}, {'id': 'OG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'OG002', 'title': 'Linaclotide DR2 30 μg', 'description': 'Linaclotide DR2 30 μg QD for 12 weeks'}, {'id': 'OG003', 'title': 'Linaclotide DR2 100 μg', 'description': 'Linaclotide DR2 100 μg QD for 12 weeks'}, {'id': 'OG004', 'title': 'Linaclotide DR2 300 μg', 'description': 'Linaclotide DR2 300 μg QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.370', 'spread': '0.241', 'groupId': 'OG000'}, {'value': '-1.938', 'spread': '0.241', 'groupId': 'OG001'}, {'value': '-1.825', 'spread': '0.238', 'groupId': 'OG002'}, {'value': '-1.669', 'spread': '0.235', 'groupId': 'OG003'}, {'value': '-1.628', 'spread': '0.239', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.569', 'ciLowerLimit': '-1.214', 'ciUpperLimit': '0.076', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1669', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.455', 'ciLowerLimit': '-1.102', 'ciUpperLimit': '0.191', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3637', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.299', 'ciLowerLimit': '-0.947', 'ciUpperLimit': '0.348', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4333', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.258', 'ciLowerLimit': '-0.905', 'ciUpperLimit': '0.389', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5528', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Trend test performed using linear contrast statement for each DR formulation with placebo.', 'statisticalMethod': 'Trend Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to Week 12', 'description': 'Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant\'s weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks'}, {'id': 'OG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'OG002', 'title': 'Linaclotide DR1 30 μg', 'description': 'Linaclotide DR1 30 μg QD for 12 weeks'}, {'id': 'OG003', 'title': 'Linaclotide DR1 100 μg', 'description': 'Linaclotide DR1 100 μg QD for 12 weeks'}, {'id': 'OG004', 'title': 'Linaclotide DR1 300 μg', 'description': 'Linaclotide DR1 300 μg QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.115', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '2.107', 'spread': '0.286', 'groupId': 'OG001'}, {'value': '1.163', 'spread': '0.278', 'groupId': 'OG002'}, {'value': '1.414', 'spread': '0.283', 'groupId': 'OG003'}, {'value': '1.776', 'spread': '0.279', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.992', 'ciLowerLimit': '0.228', 'ciUpperLimit': '1.756', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.048', 'ciLowerLimit': '-0.716', 'ciUpperLimit': '0.812', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4447', 'groupIds': ['OG003'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.299', 'ciLowerLimit': '-0.469', 'ciUpperLimit': '1.067', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0904', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.662', 'ciLowerLimit': '-0.104', 'ciUpperLimit': '1.428', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0700', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Trend test performed using linear contrast statement for each DR formulation with placebo.', 'statisticalMethod': 'Trend Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to Week 12', 'description': "A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.", 'unitOfMeasure': 'CSBMs/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks'}, {'id': 'OG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'OG002', 'title': 'Linaclotide DR2 30 μg', 'description': 'Linaclotide DR2 30 μg QD for 12 weeks'}, {'id': 'OG003', 'title': 'Linaclotide DR2 100 μg', 'description': 'Linaclotide DR2 100 μg QD for 12 weeks'}, {'id': 'OG004', 'title': 'Linaclotide DR2 300 μg', 'description': 'Linaclotide DR2 300 μg QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.115', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '2.107', 'spread': '0.286', 'groupId': 'OG001'}, {'value': '1.275', 'spread': '0.282', 'groupId': 'OG002'}, {'value': '1.019', 'spread': '0.278', 'groupId': 'OG003'}, {'value': '0.869', 'spread': '0.282', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.992', 'ciLowerLimit': '0.228', 'ciUpperLimit': '1.756', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6801', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.161', 'ciLowerLimit': '-0.604', 'ciUpperLimit': '0.925', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8069', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.095', 'ciLowerLimit': '-0.861', 'ciUpperLimit': '0.670', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5275', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference (Lin-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.246', 'ciLowerLimit': '-1.011', 'ciUpperLimit': '0.519', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4201', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Trend test performed using linear contrast statement for each DR formulation with placebo.', 'statisticalMethod': 'Trend Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to Week 12', 'description': "A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.", 'unitOfMeasure': 'CSBMs/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).'}, {'type': 'PRIMARY', 'title': 'Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks'}, {'id': 'OG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'OG002', 'title': 'Linaclotide DR1 30 μg', 'description': 'Linaclotide DR1 30 μg QD for 12 weeks'}, {'id': 'OG003', 'title': 'Linaclotide DR1 100 μg', 'description': 'Linaclotide DR1 100 μg QD for 12 weeks'}, {'id': 'OG004', 'title': 'Linaclotide DR1 300 μg', 'description': 'Linaclotide DR1 300 μg QD for 12 weeks'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '0.79', 'ciUpperLimit': '3.70', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4399', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '0.61', 'ciUpperLimit': '3.17', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5540', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.85', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0262', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.39', 'ciLowerLimit': '1.10', 'ciUpperLimit': '5.19', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0249', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.', 'statisticalMethod': 'Correlation test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 12', 'description': 'A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.\n\n* Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.\n* Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.\n* Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.\n\nA participant with \\<4 days of completed eDiary data for that week is not considered a responder for that week.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).'}, {'type': 'PRIMARY', 'title': 'Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: QD for 12 weeks'}, {'id': 'OG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'OG002', 'title': 'Linaclotide DR2 30 μg', 'description': 'Linaclotide DR2 30 μg QD for 12 weeks'}, {'id': 'OG003', 'title': 'Linaclotide DR2 100 μg', 'description': 'Linaclotide DR2 100 μg QD for 12 weeks'}, {'id': 'OG004', 'title': 'Linaclotide DR2 300 μg', 'description': 'Linaclotide DR2 300 μg QD for 12 weeks'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '0.79', 'ciUpperLimit': '3.70', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7710', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.58', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8021', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.58', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8011', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.37', 'ciUpperLimit': '2.14', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8578', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.', 'statisticalMethod': 'Correlation test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 12', 'description': 'A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.\n\n* Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.\n* Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.\n* Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.\n\nA participant with \\<4 days of completed eDiary data for that week is not considered a responder for that week.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: once daily (QD) for 12 weeks'}, {'id': 'FG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide immediate release (IR) formulation: 290 μg QD for 12 weeks'}, {'id': 'FG002', 'title': 'Linaclotide DR1 30 μg', 'description': 'Linaclotide delayed release formulation 1 (DR1) 30 μg QD for 12 weeks'}, {'id': 'FG003', 'title': 'Linaclotide DR1 100 μg', 'description': 'Linaclotide DR1 100 μg QD for 12 weeks'}, {'id': 'FG004', 'title': 'Linaclotide DR1 300 μg', 'description': 'Linaclotide DR1 300 μg QD for 12 weeks'}, {'id': 'FG005', 'title': 'Linaclotide DR2 30 μg', 'description': 'Linaclotide delayed release formulation 2 (DR2) 30 μg QD for 12 weeks'}, {'id': 'FG006', 'title': 'Linaclotide DR2 100 μg', 'description': 'Linaclotide DR2 100 μg QD for 12 weeks'}, {'id': 'FG007', 'title': 'Linaclotide DR2 300 μg', 'description': 'Linaclotide DR2 300 μg QD for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '67'}, {'groupId': 'FG005', 'numSubjects': '67'}, {'groupId': 'FG006', 'numSubjects': '66'}, {'groupId': 'FG007', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '60'}, {'groupId': 'FG007', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Other Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 227 of the 759 participants who signed an informed consent form and entered the Pretreatment Period were not randomized into the study, and were identified as pretreatment failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}, {'value': '66', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}, {'value': '532', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: once daily (QD) for 12 weeks'}, {'id': 'BG001', 'title': 'Linaclotide IR 290 μg', 'description': 'Linaclotide IR formulation: 290 μg QD for 12 weeks'}, {'id': 'BG002', 'title': 'Linaclotide DR1 30 μg', 'description': 'Linaclotide DR1 30 μg QD for 12 weeks'}, {'id': 'BG003', 'title': 'Linaclotide DR1 100 μg', 'description': 'Linaclotide DR1 100 μg QD for 12 weeks'}, {'id': 'BG004', 'title': 'Linaclotide DR1 300 μg', 'description': 'Linaclotide DR1 300 μg QD for 12 weeks'}, {'id': 'BG005', 'title': 'Linaclotide DR2 30 μg', 'description': 'Linaclotide DR2 30 μg QD for 12 weeks'}, {'id': 'BG006', 'title': 'Linaclotide DR2 100 μg', 'description': 'Linaclotide DR2 100 μg QD for 12 weeks'}, {'id': 'BG007', 'title': 'Linaclotide DR2 300 μg', 'description': 'Linaclotide DR2 300 μg QD for 12 weeks'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '44.8', 'spread': '14.9', 'groupId': 'BG002'}, {'value': '44.7', 'spread': '13.7', 'groupId': 'BG003'}, {'value': '46.5', 'spread': '12.7', 'groupId': 'BG004'}, {'value': '42.3', 'spread': '12.6', 'groupId': 'BG005'}, {'value': '47.9', 'spread': '12.8', 'groupId': 'BG006'}, {'value': '45.2', 'spread': '14.4', 'groupId': 'BG007'}, {'value': '45.1', 'spread': '13.8', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}, {'value': '62', 'groupId': 'BG007'}, {'value': '443', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '89', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '127', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}, {'value': '45', 'groupId': 'BG007'}, {'value': '405', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '344', 'groupId': 'BG008'}]}]}, {'title': 'Non-Caucasian', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '188', 'groupId': 'BG008'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '145', 'groupId': 'BG008'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '35', 'groupId': 'BG008'}]}]}, {'title': 'Other, Not Specified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Abdominal Pain', 'classes': [{'categories': [{'measurements': [{'value': '6.41', 'spread': '1.85', 'groupId': 'BG000'}, {'value': '6.18', 'spread': '1.77', 'groupId': 'BG001'}, {'value': '6.20', 'spread': '1.59', 'groupId': 'BG002'}, {'value': '6.18', 'spread': '1.67', 'groupId': 'BG003'}, {'value': '6.38', 'spread': '1.82', 'groupId': 'BG004'}, {'value': '6.07', 'spread': '1.68', 'groupId': 'BG005'}, {'value': '6.48', 'spread': '1.53', 'groupId': 'BG006'}, {'value': '6.09', 'spread': '1.68', 'groupId': 'BG007'}, {'value': '6.25', 'spread': '1.69', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Based on 11-point numerical rating scale assessing symptom "at its worst in past 24 hours." 0=No symptom; 10=Worst possible.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Complete Spontaneous Bowel Movement (CBSM) Weekly Rate', 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.56', 'groupId': 'BG000'}, {'value': '0.34', 'spread': '0.61', 'groupId': 'BG001'}, {'value': '0.35', 'spread': '0.56', 'groupId': 'BG002'}, {'value': '0.22', 'spread': '0.46', 'groupId': 'BG003'}, {'value': '0.27', 'spread': '0.54', 'groupId': 'BG004'}, {'value': '0.35', 'spread': '0.62', 'groupId': 'BG005'}, {'value': '0.31', 'spread': '0.61', 'groupId': 'BG006'}, {'value': '0.33', 'spread': '0.56', 'groupId': 'BG007'}, {'value': '0.31', 'spread': '0.57', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'CBSM/week', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-04', 'size': 2207169, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-08T18:12', 'hasProtocol': False}, {'date': '2015-10-09', 'size': 1899887, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-09T13:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 759}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2015-09-22', 'resultsFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-09', 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo', 'timeFrame': 'Baseline, up to Week 12', 'description': 'Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant\'s weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.'}, {'measure': 'Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo', 'timeFrame': 'Baseline, up to Week 12', 'description': 'Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant\'s weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.'}, {'measure': 'Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo', 'timeFrame': 'Baseline, up to Week 12', 'description': "A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week."}, {'measure': 'Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo', 'timeFrame': 'Baseline, up to Week 12', 'description': "A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week."}, {'measure': 'Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo', 'timeFrame': 'up to Week 12', 'description': 'A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.\n\n* Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.\n* Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.\n* Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.\n\nA participant with \\<4 days of completed eDiary data for that week is not considered a responder for that week.'}, {'measure': 'Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo', 'timeFrame': 'up to Week 12', 'description': 'A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.\n\n* Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.\n* Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.\n* Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.\n\nA participant with \\<4 days of completed eDiary data for that week is not considered a responder for that week.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome With Constipation']}, 'referencesModule': {'references': [{'pmid': '33065589', 'type': 'DERIVED', 'citation': 'Chey WD, Sayuk GS, Bartolini W, Reasner DS, Fox SM, Bochenek W, Boinpally R, Shea E, Tripp K, Borgstein N. Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. Am J Gastroenterol. 2021 Feb 1;116(2):354-361. doi: 10.14309/ajg.0000000000000967.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \\[IR\\] formulation of linaclotide).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings\n* Patient has no clinically significant findings on a physical examination and clinical laboratory tests\n* Patient meets protocol criteria for diagnosis of IBS-C\n* Patient demonstrates continued IBS-C through Pretreatment Period\n* Patient maintains a minimum level of compliance with daily diary\n\nExclusion Criteria:\n\n* Patient has history of loose or watery stools\n* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain\n* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility\n* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments'}, 'identificationModule': {'nctId': 'NCT02559206', 'briefTitle': 'Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ironwood Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation', 'orgStudyIdInfo': {'id': 'MCP-103-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 μg linaclotide DR1 and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'EXPERIMENTAL', 'label': '100 μg linaclotide DR1 and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'EXPERIMENTAL', 'label': '300 μg linaclotide DR1 and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'EXPERIMENTAL', 'label': '30 μg linaclotide DR2 and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'EXPERIMENTAL', 'label': '100 μg linaclotide DR2 and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'EXPERIMENTAL', 'label': '300 μg linaclotide DR2 and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'EXPERIMENTAL', 'label': '290 μg linaclotide IR and placebo', 'interventionNames': ['Drug: Linaclotide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'Linaclotide', 'type': 'DRUG', 'description': 'Oral, once daily', 'armGroupLabels': ['100 μg linaclotide DR1 and placebo', '100 μg linaclotide DR2 and placebo', '290 μg linaclotide IR and placebo', '30 μg linaclotide DR1 and placebo', '30 μg linaclotide DR2 and placebo', '300 μg linaclotide DR1 and placebo', '300 μg linaclotide DR2 and placebo']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Oral, once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ironwood Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Ironwood 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