Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 10:39 PM
Study NCT ID:
NCT01827592
Status:
TERMINATED
Last Update Posted:
2015-10-20
First Post:
2013-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C581303', 'term': 'elobixibat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the early termination of the study, outcomes were presented only for descriptive purposes.'}}, 'adverseEventsModule': {'timeFrame': '34 weeks', 'description': 'The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.', 'eventGroups': [{'id': 'EG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.', 'otherNumAtRisk': 125, 'otherNumAffected': 42, 'seriousNumAtRisk': 125, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.', 'otherNumAtRisk': 126, 'otherNumAffected': 28, 'seriousNumAtRisk': 126, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.', 'otherNumAtRisk': 124, 'otherNumAffected': 23, 'seriousNumAtRisk': 124, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Complete Spontaneous Bowel Movement (CSBM) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first 12 weeks', 'description': 'This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consisted of all randomized (as planned) patients.'}, {'type': 'SECONDARY', 'title': 'Occurrence of CSBM Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the first 24 hours of treatment initiation', 'description': "This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').", 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients was used for assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '2.44'}, {'value': '2.44', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '2.84'}, {'value': '1.55', 'groupId': 'OG002', 'lowerLimit': '1.15', 'upperLimit': '1.95'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.', 'unitOfMeasure': 'SBM per week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Stool Consistency of SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.58'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.52'}, {'value': '0.83', 'groupId': 'OG002', 'lowerLimit': '0.66', 'upperLimit': '1.00'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.\n\nType 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .\n\nFor a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.', 'unitOfMeasure': 'Units on BSFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients.'}, {'type': 'SECONDARY', 'title': 'Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 weeks', 'description': 'This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.\n\nPAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 \\[none of the time or not at all\\] to 4 \\[all of the time or extremely\\]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.\n\nTotal PAC-QOL score was averaged from the individual item score.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Degree of Straining of SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '-0.88'}, {'value': '-1.04', 'groupId': 'OG001', 'lowerLimit': '-1.17', 'upperLimit': '-0.91'}, {'value': '-0.91', 'groupId': 'OG002', 'lowerLimit': '-1.05', 'upperLimit': '-0.78'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).\n\nFor a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Abdominal Bloating Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'groupId': 'OG000', 'lowerLimit': '-0.61', 'upperLimit': '-0.38'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '-0.40'}, {'value': '-0.35', 'groupId': 'OG002', 'lowerLimit': '-0.47', 'upperLimit': '-0.24'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).\n\nFor a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Abdominal Discomfort Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'OG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '-0.32'}, {'value': '-0.46', 'groupId': 'OG001', 'lowerLimit': '-0.57', 'upperLimit': '-0.35'}, {'value': '-0.38', 'groupId': 'OG002', 'lowerLimit': '-0.49', 'upperLimit': '-0.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).\n\nFor a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized (as planned) patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.'}, {'id': 'FG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'FG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized patients.', 'groupId': 'FG000', 'numSubjects': '126'}, {'comment': 'Randomized patients.', 'groupId': 'FG001', 'numSubjects': '126'}, {'comment': 'Randomized patients.', 'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'comment': '1 patient withdrew consent before getting the treatment.', 'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '76'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': "Patient's substantial non-compliance", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Trial terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'The trial included a 4-week Screening Period and a 2-week Pretreatment Period prior to patient randomization to a 26-week Treatment Period. A total of 909 patients were screened in the trial and of these 533 patients were excluded due to screening failure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '376', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'EBX 10', 'description': 'Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'BG001', 'title': 'EBX 5', 'description': 'Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'BG002', 'title': 'PLCBO', 'description': 'Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '46.1', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '46.6', 'spread': '14.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weekly number of CSBM', 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.66', 'groupId': 'BG000'}, {'value': '0.44', 'spread': '0.75', 'groupId': 'BG001'}, {'value': '0.54', 'spread': '0.82', 'groupId': 'BG002'}, {'value': '0.45', 'spread': '0.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').\n\nBaseline value for the number of CSBM per week was defined as the average of the numbers of CSBM per week for over the 2-week Pretreatment Period.", 'unitOfMeasure': 'CSBM per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly number of SBM', 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'spread': '1.34', 'groupId': 'BG000'}, {'value': '2.13', 'spread': '1.27', 'groupId': 'BG001'}, {'value': '2.31', 'spread': '1.43', 'groupId': 'BG002'}, {'value': '2.21', 'spread': '1.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'SBM was defined as a bowel movement that occurs in the absence of a laxative use or manual disimpaction.\n\nBaseline value for the number of SBM was defined as the average of the numbers of SBM per week for over the 2-week Pretreatment Period.', 'unitOfMeasure': 'SBM per week', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention-to-treat population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'whyStopped': 'Terminated due to a distribution issue with the trial medication', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-04-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2013-04-05', 'dispFirstSubmitQcDate': '2015-04-07', 'resultsFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2013-04-05', 'dispFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-22', 'studyFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Complete Spontaneous Bowel Movement (CSBM) Response', 'timeFrame': 'During the first 12 weeks', 'description': 'This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of CSBM Response', 'timeFrame': 'Within the first 24 hours of treatment initiation', 'description': "This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete')."}, {'measure': 'Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.'}, {'measure': 'Change From Baseline in Weekly Stool Consistency of SBMs', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.\n\nType 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .\n\nFor a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.'}, {'measure': 'Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder', 'timeFrame': 'At 12 weeks', 'description': 'This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.\n\nPAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 \\[none of the time or not at all\\] to 4 \\[all of the time or extremely\\]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.\n\nTotal PAC-QOL score was averaged from the individual item score.'}, {'measure': 'Change From Baseline in Weekly Degree of Straining of SBMs', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).\n\nFor a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.'}, {'measure': 'Change From Baseline in Weekly Abdominal Bloating Score', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).\n\nFor a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.'}, {'measure': 'Change From Baseline in Weekly Abdominal Discomfort Score', 'timeFrame': 'From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period', 'description': 'The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).\n\nFor a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Idiopathic Constipation']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.', 'detailedDescription': 'The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 26-week Treatment Period in patients with chronic idiopathic constipation. Patients were followed-up for 2 weeks after end of the Treatment Period.\n\nThe assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of Treatment Period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the treatment.\n\nThe trial was early terminated due to a distribution issue with the trial medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) ≥18.5 but \\<35.0 kg/m\\^2\n* Male or female ≥18 years of age\n* Reports \\<3 spontaneous Bowel movements (BM) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative:\n\n 1. Straining during at least 25% of defecations\n 2. Lumpy or hard stools during at least 25% of defecations\n 3. Sensation of incomplete evacuation during at least 25% of defecations\n* Is ambulatory and community dwelling\n* An initial colonoscopy is required if recommended by national guidelines\n\nExclusion Criteria:\n\n* Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for \\>25% of BMs\n* The patient reports a BSFS of 6 or 7 during the Pretreatment Period\n* Has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms\n* Has a structural abnormality of the GI tract or a disease or condition that can affect Gastrointestinal (GI) motility\n* Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, megacolon, megarectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer.\n* Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis\n* Has a potential central nervous system (CNS) cause of constipation (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis)\n* Has intestinal/rectal prolapse or other known pelvic floor dysfunction\n* Commonly uses digital manoeuvres (perianal pressure or digital disimpaction) or vaginal splinting to facilitate the passage of a bowel movement\n* Has a history of diabetic neuropathy\n* Has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening\n* Has a history of cancer with last date of proven disease activity/presence of malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix\n* Known human immunodeficiency virus (HIV) or Hepatitis B/C (HBV/HCV) infection\n* Has a history of hospitalization for any psychiatric disorder, or any suicide attempt in the 2 years prior to Screening\n* Is actively abusing alcohol or drugs or has a history of alcohol or drug abuse during the 6 months prior to Screening\n* Is being treated for hypothyroidism, but the dose of medication has not been stable for at least 3 months at the time of Screening\n* Is a pregnant, breast-feeding, or lactating woman"}, 'identificationModule': {'nctId': 'NCT01827592', 'briefTitle': '26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients With Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks', 'orgStudyIdInfo': {'id': '000079'}, 'secondaryIdInfos': [{'id': '2012-005587-94', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBX 10', 'description': 'Elobixibat 10 mg/day', 'interventionNames': ['Drug: Elobixibat 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'EBX 5', 'description': 'Elobixibat 5 mg/day', 'interventionNames': ['Drug: Elobixibat 5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLCBO', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Elobixibat 10 mg', 'type': 'DRUG', 'otherNames': ['A3309'], 'description': 'Elobixibat 10 mg/day', 'armGroupLabels': ['EBX 10']}, {'name': 'Elobixibat 5 mg', 'type': 'DRUG', 'otherNames': ['A3309'], 'description': 'Elobixibat 5 mg/day', 'armGroupLabels': ['EBX 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['PLCBO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'G and L Research, LLC', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Adobe Gastroenterology Research, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Skyline Research LLC', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GW Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Paradigm Clinical, Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Therapeutics Consortium', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Pulmonary Associates of Brandon', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'In Vivo Clinical Research, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Medsearch Professional Group, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'The Community Research of South Florida', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Gastrointestinal Disorders', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research, LLC', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastroenterology and Hepatology Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Research Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Advanced Gastroenterology', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma CR, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Institute of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastroenterology Group of Naples', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Clinical Research', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Elite Clinical Trials, Inc.', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'MediSphere Medical Research Center, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Hollywood', 'state': 'Maryland', 'country': 'United States', 'facility': 'MidAtlantic Medical Research Centers, Philip J. 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