Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT01722318
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2012-11-02
Is NOT Gene Therapy:
False
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': {'phone': '212-297-0020', 'title': 'Dr. Patrick H. Griffin', 'organization': 'Synergy Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide', 'otherNumAtRisk': 85, 'otherNumAffected': 18, 'seriousNumAtRisk': 85, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks\n\nPlecanatide', 'otherNumAtRisk': 85, 'otherNumAffected': 29, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide', 'otherNumAtRisk': 86, 'otherNumAffected': 19, 'seriousNumAtRisk': 86, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide', 'otherNumAtRisk': 85, 'otherNumAffected': 31, 'seriousNumAtRisk': 85, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks\n\nPlacebo', 'otherNumAtRisk': 86, 'otherNumAffected': 12, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks'}, {'id': 'OG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '0.265', 'groupId': 'OG001'}, {'value': '2.74', 'spread': '0.260', 'groupId': 'OG002'}, {'value': '2.44', 'spread': '0.262', 'groupId': 'OG003'}, {'value': '1.27', 'spread': '0.260', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks Treatment Period', 'description': 'The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.', 'unitOfMeasure': 'CSBMs per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks'}, {'id': 'OG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '0.20', 'groupId': 'OG003'}, {'value': '-1.4', 'spread': '0.20', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12-Week Treatment Period', 'description': "Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized patients who received at least 1 dose of study drug and who had at least 1 post-baseline Bowel Movement (BM) assessment was the primary analysis population for efficacy endpoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks'}, {'id': 'OG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '2.49', 'spread': '0.143', 'groupId': 'OG002'}, {'value': '2.24', 'spread': '0.145', 'groupId': 'OG003'}, {'value': '1.01', 'spread': '0.143', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12-Week Treatment Period', 'description': 'The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \\[BSFS\\] from 1 to 7.\n\n1. = separate hard lumps like nuts (difficult 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': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks'}, {'id': 'OG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '-1.3', 'spread': '0.23', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12-Week Treatment Period', 'description': 'The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'FG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'FG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'FG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '18'}]}]}], 'preAssignmentDetails': 'The Enrollment number in the Protocol Section was changed from 350 to 428 participants to reflect the actual enrollment number.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '423', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'BG001', 'title': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'BG002', 'title': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'BG003', 'title': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks\n\nPlecanatide'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks\n\nPlacebo'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '12.02', 'groupId': 'BG000'}, {'value': '44.6', 'spread': '12.58', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '12.89', 'groupId': 'BG002'}, {'value': '45.3', 'spread': '12.00', 'groupId': 'BG003'}, {'value': '45.4', 'spread': '12.02', 'groupId': 'BG004'}, {'value': '45.9', 'spread': '12.30', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '344', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '79', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Randomized Population (428 patients) in Participant Flow differs from the mITT Population (423 patients) because 1 patient was randomized and not dosed, 1 patient was dosed but had no post-baseline efficacy assessments, and 3 duplicate patient records (2 patients who were seen at 2 sites and 1 patient who was seen at 3 sites)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2012-11-02', 'resultsFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-13', 'studyFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)', 'timeFrame': '12 weeks Treatment Period', 'description': 'The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)', 'timeFrame': '12-Week Treatment Period', 'description': "Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst."}, {'measure': 'Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)', 'timeFrame': '12-Week Treatment Period', 'description': 'The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \\[BSFS\\] from 1 to 7.\n\n1. = separate hard lumps like nuts (difficult 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 Scores Over 12-Week Treatment Period (mITT Population)', 'timeFrame': '12-Week Treatment Period', 'description': 'The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome Characterized by Constipation']}, 'descriptionModule': {'briefSummary': 'This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.', 'detailedDescription': "This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18-75, inclusive\n* Body Mass Index = 18-35 kg/m2, inclusive\n* Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.\n* Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.\n* Hard or lumpy stools ≥ 25 % of defecations\n* Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period\n* Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods\n* Willing to maintain a stable diet during the study.\n* Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.\n\nExclusion Criteria:\n\n* Loose stool (mushy) or watery stool in the absence of any laxative or prohibited medicine for \\> 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment period\n* Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.\n* Active peptic ulcer disease not adequately treated or not stable\n* History of cathartic colon, laxative, enema abuse, or ischemic colitis.\n* Fecal impaction within 3 months of screening\n* Patient has had /has any: structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain\n* Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.\n* Major surgery within 60 days of screening.'}, 'identificationModule': {'nctId': 'NCT01722318', 'acronym': 'CIBS', '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, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)', 'orgStudyIdInfo': {'id': 'SP304-20212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plecanatide 0.3mg', 'description': 'Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plecanatide 1.0mg', 'description': 'Plecanatide 1.0mg one tablet by mouth daily for 12 weeks', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plecanatide 3.0mg', 'description': 'Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plecanatide 9.0mg', 'description': 'Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks', 'interventionNames': ['Drug: Plecanatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, one tablet by mouth daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Plecanatide', 'type': 'DRUG', 'otherNames': ['Trulance'], 'armGroupLabels': ['Plecanatide 0.3mg', 'Plecanatide 1.0mg', 'Plecanatide 3.0mg', 'Plecanatide 9.0mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Health Specialists of the Southeast', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arrowhead Family Health Center PC dba Arrowhead Health Centers', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Research Associates, LLC', 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States', 'facility': 'Mount Vernon Clinical Research, LLC', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '83616', 'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': 'CTL Research', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'zip': '60602', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Medex Healthcare Research, Inc', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Gastroenterology Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '67010', 'city': 'Augusta', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 37.68668, 'lon': -96.9767}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Integrity, LLC', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, 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'facility': 'MGG Group Co., Inc., Chevy Chase Clinical Research', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Clinical Trials', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novex Clinical Research, LLC', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bay State Clinical Trials, Inc.', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '48118', 'city': 'Chelsea', 'state': 'Michigan', 'country': 'United States', 'facility': 'IHA Chelsea Family & Internal Medicine', 'geoPoint': {'lat': 42.31807, 'lon': -84.02181}}, {'zip': '48047', 'city': 'Chesterfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Research Institute of Michigan, LLC', 'geoPoint': {'lat': 42.66281, 'lon': -82.84242}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Center for Digestive Health', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55318', 'city': 'Chaska', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ridgeview Research', 'geoPoint': {'lat': 44.78941, 'lon': -93.60218}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39531', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The Center for Clinical Trials', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Gastrointestinal Associates, PA', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63128', 'city': 'St Louis', 'state': 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'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Gastroenterology Associates, PA', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28607', 'city': 'Boone', 'state': 'North Carolina', 'country': 'United States', 'facility': 'MediSpect Medical Research, LLC', 'geoPoint': {'lat': 36.21679, 'lon': -81.67455}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Trials of North Carolina, LLC', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Digestive Health Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'On Site Clinical, LLC', 'geoPoint': 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