Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-17 @ 2:00 PM
Study NCT ID:
NCT02387359
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2015-01-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584575', 'term': 'plecanatide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ejaeger@synergypharma.com', 'phone': '646-675-7283', 'title': 'VP Regulatory Affairs & Clinical QA', 'organization': 'Synergy Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'A total of 1054 patients were randomized, of which two patients did not receive the study drug (6 mg) and resulted in a total of 1052 patients in the Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks', 'otherNumAtRisk': 354, 'deathsNumAtRisk': 354, 'otherNumAffected': 16, 'seriousNumAtRisk': 354, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks', 'otherNumAtRisk': 351, 'deathsNumAtRisk': 351, 'otherNumAffected': 37, 'seriousNumAtRisk': 351, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks', 'otherNumAtRisk': 347, 'deathsNumAtRisk': 347, 'otherNumAffected': 28, 'seriousNumAtRisk': 347, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}], 'seriousEvents': [{'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Hepatic enzyme increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Biplar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Overall Responders - ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Sustained Efficacy Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Stool Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.06', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.918', 'groupId': 'OG001'}, {'value': '1.98', 'spread': '0.913', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 change from baseline', 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.357', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '1.592', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '1.593', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-Week', 'description': 'Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:\n\n1. Separate hard lumps, like nuts (hard to pass)\n2. Sausage-shaped but lumpy\n3. Like a sausage but with cracks on its surface\n4. Like a sausage or snake, smooth and soft\n5. Soft blobs with clear-cut edges (passed easily)\n6. Fluffy pieces with ragged edges, a mushy stool\n7. Watery, no solid pieces, entirely liquid', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Straining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.39', 'spread': '1.991', 'groupId': 'OG000'}, {'value': '6.47', 'spread': '1.828', 'groupId': 'OG001'}, {'value': '6.50', 'spread': '1.822', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 change from baseline', 'categories': [{'measurements': [{'value': '-1.87', 'spread': '2.464', 'groupId': 'OG000'}, {'value': '-2.69', 'spread': '2.422', 'groupId': 'OG001'}, {'value': '-2.88', 'spread': '2.464', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-week', 'description': 'Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CSBM Frequency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.440', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.465', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '0.527', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 change from baseline', 'categories': [{'measurements': [{'value': '0.86', 'spread': '1.904', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '2.565', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '2.586', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-Week', 'description': 'Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.', 'unitOfMeasure': 'CSBMs per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a SBM Within 24 Hours After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 hours after first dose of study drug', 'description': 'Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '349', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'OG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.10', 'spread': '1.793', 'groupId': 'OG000'}, {'value': '5.94', 'spread': '1.704', 'groupId': 'OG001'}, {'value': '5.95', 'spread': '1.760', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 change from baseline', 'categories': [{'measurements': [{'value': '-1.79', 'spread': '2.196', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '2.215', 'groupId': 'OG001'}, {'value': '-2.46', 'spread': '2.370', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12-Week', 'description': 'Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'FG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'FG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '351'}, {'groupId': 'FG002', 'numSubjects': '349'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '309'}, {'groupId': 'FG002', 'numSubjects': '293'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '56'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '1054', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Matching Placebo', 'description': 'Placebo tablets dosed once daily for 12 weeks'}, {'id': 'BG001', 'title': '3.0 mg Plecanatide', 'description': 'Plecanatide 3.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'BG002', 'title': '6.0 mg Plecanatide', 'description': 'Plecanatide 6.0 mg tablets dosed once daily for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '13.71', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '13.76', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '13.34', 'groupId': 'BG002'}, {'value': '43.1', 'spread': '13.60', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}, {'value': '805', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1054}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2015-01-20', 'resultsFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-13', 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Overall Responders - ITT Population', 'timeFrame': '12 Weeks', 'description': 'An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.'}, {'measure': 'Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks', 'timeFrame': '12 Weeks', 'description': 'An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.'}, {'measure': 'Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks', 'timeFrame': '12 weeks', 'description': 'A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Number of Sustained Efficacy Responders', 'timeFrame': '12 weeks', 'description': 'A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.'}, {'measure': 'Change From Baseline in Stool Consistency', 'timeFrame': 'Baseline and 12-Week', 'description': 'Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:\n\n1. Separate hard lumps, like nuts (hard to pass)\n2. Sausage-shaped but lumpy\n3. Like a sausage but with cracks on its surface\n4. Like a sausage or snake, smooth and soft\n5. Soft blobs with clear-cut edges (passed easily)\n6. Fluffy pieces with ragged edges, a mushy stool\n7. Watery, no solid pieces, entirely liquid'}, {'measure': 'Change From Baseline in Straining', 'timeFrame': 'Baseline and 12-week', 'description': 'Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).'}, {'measure': 'Change From Baseline in CSBM Frequency Rate', 'timeFrame': 'Baseline and 12-Week', 'description': 'Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.'}, {'measure': 'Number of Patients With a SBM Within 24 Hours After the First Dose', 'timeFrame': 'Up to 24 hours after first dose of study drug', 'description': 'Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug'}, {'measure': 'Change From Baseline in Abdominal Pain', 'timeFrame': 'Baseline and 12-Week', 'description': 'Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome Characterized by Constipation']}, 'referencesModule': {'references': [{'pmid': '41214272', 'type': 'DERIVED', 'citation': 'Brenner DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC. The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. J Gastroenterol Hepatol. 2025 Dec;40(12):2890-2897. doi: 10.1111/jgh.70119. Epub 2025 Nov 10.'}, {'pmid': '37332239', 'type': 'DERIVED', 'citation': 'Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.'}, {'pmid': '32660770', 'type': 'DERIVED', 'citation': 'Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.', 'detailedDescription': "This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.\n\nScreening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.\n\nTreatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.\n\nPost-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.\n\nThe planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C\n\nExclusion Criteria:\n\n* Refusal or inability to sign informed consent for the trial\n* Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires\n* BMI \\> 35 or \\< 18\n* Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial\n* Women who are pregnant or lactating\n* Diagnosis of IBS-D or IBS-M\n* Organic or obstructive disease of the small or large intestine\n* Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)\n* Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication\n* Unstable medical illness\n* Bilirubin \\> 3X ULN in the absence of a conjugation defect\n* Any laboratory value \\> 3X ULN unless discussed and approved by the study Medical Monitor'}, 'identificationModule': {'nctId': 'NCT02387359', 'acronym': 'IBS-C', 'briefTitle': 'The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)', 'orgStudyIdInfo': {'id': 'SP304203-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3.0 mg plecanatide', 'description': 'Plecanatide 3.0 mg dosed daily for 12 weeks', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6.0 mg plecanatide', 'description': 'Plecanatide 6.0 mg dosed daily for 12 weeks', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Matching placebo', 'description': 'Placebo dosed daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Plecanatide', 'type': 'DRUG', 'armGroupLabels': ['3.0 mg plecanatide', '6.0 mg plecanatide']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 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