Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-03-27 @ 5:27 AM
Study NCT ID:
NCT05036369
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2021-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vibrant Capsule vs. Placebo for Patient Suffering From Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@vibrantgastro.com', 'phone': '+972 046663322', 'title': 'Clinical trials manager', 'organization': 'VibrantGastro'}, 'certainAgreement': {'otherDetails': 'Permission to use study data is required', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The Safety reporting conducted throughout the treatment period (8 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 16, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 11, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensation of Vibration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'notes': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTI', 'notes': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal Spasm', 'notes': 'Esophageal Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'notes': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalized due to bleeding from the catheter port', 'notes': 'Hospitalized due to bleeding from the catheter port', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CSBM 1 Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'CSBM1 Success Rate: defined as the number of Participants with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.\n\nNOTE:\n\nA spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver.\n\nA complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'PRIMARY', 'title': 'CSBM2 Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'CSBM2 Success Rate: defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.\n\nNOTE:\n\nA spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver.\n\nA complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Straining Based on the Subject's Assessment Recorded in Daily Diaries", 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-3.14', 'upperLimit': '-1.66'}, {'value': '-1.70', 'groupId': 'OG001', 'lowerLimit': '-2.31', 'upperLimit': '-1.08'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 10 weeks', 'description': "Change from baseline in average straining based on the subject's account in daily diary reports.\n\nThe straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'CSBM1 Expanded Success Rate,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'CSBM1 expanded success rate, defined as the number of Participants with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CSBM2 Expanded Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Stool Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.78'}, {'value': '0.81', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '1.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 10 weeks', 'description': 'Change from baseline in average stool consistency, using the Bristol Stool Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Run In non compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Change in eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study recruitment was conducted in 30 clinical sites in the USA from June 2021- September 2022', 'preAssignmentDetails': 'Following the consent process, subjects who met the study criteria started a run-in period of 2-4 weeks, during which they completed a daily eDiary with questions regrading their bowel movements and constipation symptoms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week\n\nVibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week\n\nPlacebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '12.87', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '11.65', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '12.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Native American or American Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian/ Pacific Islander', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age of constipation onset (years)', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '13.80', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '14.77', 'groupId': 'BG001'}, {'value': '31.2', 'spread': '14.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-24', 'size': 2560545, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-13T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "This is a double-blind study. The subjects and the evaluators will be blinded to the treatment allocated to each subject. Each site will assign an unblinded person that will handle all issues related to capsule administration and accountability. The unblinded person will not be involved in any subject's assessments. Rest of the site staff will remain blind throughout the study."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2021-08-02', 'resultsFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-13', 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSBM 1 Success Rate', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'CSBM1 Success Rate: defined as the number of Participants with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.\n\nNOTE:\n\nA spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver.\n\nA complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.'}, {'measure': 'CSBM2 Success Rate', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'CSBM2 Success Rate: defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.\n\nNOTE:\n\nA spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver.\n\nA complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.'}], 'secondaryOutcomes': [{'measure': "Straining Based on the Subject's Assessment Recorded in Daily Diaries", 'timeFrame': 'up to 10 weeks', 'description': "Change from baseline in average straining based on the subject's account in daily diary reports.\n\nThe straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining."}, {'measure': 'CSBM1 Expanded Success Rate,', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'CSBM1 expanded success rate, defined as the number of Participants with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.'}, {'measure': 'CSBM2 Expanded Success Rate', 'timeFrame': 'up to 8 weeks of treatment', 'description': 'defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.'}, {'measure': 'Change From Baseline in Stool Consistency', 'timeFrame': 'up to 10 weeks', 'description': 'Change from baseline in average stool consistency, using the Bristol Stool Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Constipation', 'Vibrating capsule', 'Chronic Idiopathic Constipation'], 'conditions': ['Constipation Chronic Idiopathic']}, 'descriptionModule': {'briefSummary': 'The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week', 'detailedDescription': 'The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.\n\nTwo arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo):\n\n* Vibrant Capsule administered twice a week (Monday and Thursday)\n* Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks.\n\nDuring the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation.\n\nSubjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects aged 22 years and older\n2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome IV criteria\n3. Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies\n4. Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week (as a result of at least 1 SBM and not more than 3 SBMs during each of the run-in weeks)\n5. Subjects above 50 years old or \\<50 years old and with alarm signs should have colonoscopy performed within 10 years prior to study participation. Colonoscopy results should exclude GI obstruction and/or GI malignancy\n6. Subject signed the Informed Consent Form (ICF)\n7. Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record \\[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\\]; in these circumstances, a pregnancy test will not be necessary.\n\nExclusion Criteria:\n\n1. History of complicated/obstructive diverticular disease\n2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.\n3. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)\n4. Clinical evidence of current and significant gastroparesis\n5. Use of any of the following medications:\n\n * Medications that may affect intestinal motility (including but not limited to prokinetics, anti-Parkinsonian medications, opiates, opioids, Verapamil, Nifedipine, iron, magnesium supplements, Tricyclic antidepressants (TCAs), Heparin, Warfarin and Baclofen.\n * With the exception of antidepressants (other than TCAs), thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.\n6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.\n7. Presence of cardiac pacemaker, gastric electrical stimulator or any electrical implanted device.\n8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.\n9. Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect capsule's transit\n10. History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis or achalasia\n11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study\n12. Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history\n13. Participation in another interventional clinical study within one month prior to screening.\n14. Women who are pregnant or lactating\n15. Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules\n16. Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage\n17. Subject participated in a previous Vibrant study\n18. Subjects planning to undergo MRI during the study\n19. Any known allergy to soybean, beeswax, Calcium Carbonate, Gelatin, Glycerin or Titanium dioxide\n20. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study"}, 'identificationModule': {'nctId': 'NCT05036369', 'acronym': 'Capsule', 'briefTitle': 'Vibrant Capsule vs. Placebo for Patient Suffering From Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vibrant Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation', 'orgStudyIdInfo': {'id': '280CLD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active capsule', 'description': 'The Vibrant non-biodegradable capsule administrated twice a week', 'interventionNames': ['Device: Vibrant capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week', 'interventionNames': ['Device: Placebo capsule']}], 'interventions': [{'name': 'Vibrant capsule', 'type': 'DEVICE', 'description': 'Vibrant capsule - Administered twice a week (Monday and Thursday).', 'armGroupLabels': ['Active capsule']}, {'name': 'Placebo capsule', 'type': 'DEVICE', 'description': 'Placebo Capsule administered twice a week (Monday and Thursday)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92683', 'city': 'Westminster', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Rx Clinical Research Group, Inc', 'geoPoint': {'lat': 33.75918, 'lon': -118.00673}}, {'zip': '33157', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'American Research Institute, INC', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}], 'overallOfficials': [{'name': 'Tal Malina, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vibrant Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vibrant Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}