Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-04-21 @ 8:25 PM
Study NCT ID:
NCT03342157
Status:
TERMINATED
Last Update Posted:
2024-10-03
First Post:
2017-11-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Docusate/Senna for the Treatment of Diabetic Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C011803', 'term': 'doxidan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bradley.gose@aah.org', 'phone': '414-385-2590', 'title': 'Dr. Bradley Gose', 'organization': 'Advocate Aurora Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'study stopped due to low enrollment'}}, 'adverseEventsModule': {'timeFrame': '35 days', 'eventGroups': [{'id': 'EG000', 'title': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily\n\nsenna/docusate: Stimulant laxative', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily\n\nsenna/docusate: Stimulant laxative', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily\n\nsenna/docusate: Stimulant laxative'}, {'id': 'OG001', 'title': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily\n\nsenna/docusate: Stimulant laxative'}], 'timeFrame': '28 days', 'description': 'mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis not appropriate on a sample size of 1 patient per arm.'}, {'type': 'SECONDARY', 'title': 'Frequency of Use of Breakthrough Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily\n\nsenna/docusate: Stimulant laxative'}, {'id': 'OG001', 'title': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily\n\nsenna/docusate: Stimulant laxative'}], 'timeFrame': '28 days', 'description': 'Change in the frequency of use of breakthrough medication - daily diary', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis not appropriate on a sample size of 1 patient per arm.'}, {'type': 'SECONDARY', 'title': 'Frequency of Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily\n\nsenna/docusate: Stimulant laxative'}, {'id': 'OG001', 'title': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily\n\nsenna/docusate: Stimulant laxative'}], 'timeFrame': '28 days', 'description': 'Change in the frequency of bowel movements - daily diary', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis not appropriate on a sample size of 1 patient per arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily\n\nsenna/docusate: Stimulant laxative'}, {'id': 'FG001', 'title': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily\n\nsenna/docusate: Stimulant laxative'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment occurred from 11/01/2017 through 05/11/2020 at St Lukes Medical Center utilizing outpatient and inpatient referrals from practitioners.', 'preAssignmentDetails': 'No enrolled participants were excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily\n\nsenna/docusate: Stimulant laxative'}, {'id': 'BG001', 'title': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily\n\nsenna/docusate: Stimulant laxative'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '51'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '49'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'modified gastroparesis cardinal symptom index daily diary (mGCSI-DD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Statistical analysis not appropriate on a sample size of 1.', 'unitOfMeasure': 'participants', 'populationDescription': 'Statistical analysis not appropriate on a sample size of 1.'}, {'title': 'breakthrough medication use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Statistical analysis not appropriate on a sample size of 1.', 'unitOfMeasure': 'participants', 'populationDescription': 'Statistical analysis not appropriate on a sample size of 1.'}, {'title': 'frequency of bowel habits', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Statistical analysis not appropriate on a sample size of 1.', 'unitOfMeasure': 'participants', 'populationDescription': 'Statistical analysis not appropriate on a sample size of 1.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-29', 'size': 237925, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-07T15:34', 'hasProtocol': True}, {'date': '2017-10-23', 'size': 231196, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-07T15:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2017-11-10', 'resultsFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-25', 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)', 'timeFrame': '28 days', 'description': 'mGCSI-DD uses 6-point Likert scale from 0 (none) to very severe (5)'}], 'secondaryOutcomes': [{'measure': 'Frequency of Use of Breakthrough Medication', 'timeFrame': '28 days', 'description': 'Change in the frequency of use of breakthrough medication - daily diary'}, {'measure': 'Frequency of Bowel Movements', 'timeFrame': '28 days', 'description': 'Change in the frequency of bowel movements - daily diary'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Gastroparesis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-75 years, male and non-pregnant, non-lactating females\n* Diagnosis of type 1 or type 2 diabetes mellitus\n* Clinical diagnosis of diabetic gastroparesis\n\nExclusion Criteria:\n\n* Diagnosed idiopathic gastroparesis\n* A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis\n* A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed rectal bleeding\n* Gastrointestinal cancer\n* Any active cancer\n* Prior gastric surgery\n* End-stage heart disease, liver disease, lung disease\n* Known or suspected drug abuse\n* Any condition requiring use of daily narcotics\n* Concurrent usage of mineral oil or products containing mineral oil\n* Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna"}, 'identificationModule': {'nctId': 'NCT03342157', 'briefTitle': 'Docusate/Senna for the Treatment of Diabetic Gastroparesis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis', 'orgStudyIdInfo': {'id': '17.120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose', 'description': '8.6/50 mg of senna/docusate, oral, twice daily', 'interventionNames': ['Drug: senna/docusate']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose', 'description': '8.6/50 mg of senna/docusate, oral, once daily', 'interventionNames': ['Drug: senna/docusate']}], 'interventions': [{'name': 'senna/docusate', 'type': 'DRUG', 'otherNames': ['Senokot-S'], 'description': 'Stimulant laxative', 'armGroupLabels': ['High-dose', 'Low-dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53202', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Health Care', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Bradley Gose, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}