Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-02-05 @ 8:31 AM
Study NCT ID:
NCT00760461
Status:
TERMINATED
Last Update Posted:
2017-08-18
First Post:
2008-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Domperidone in Refractory Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004294', 'term': 'Domperidone'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anish.sheth@yale.edu', 'phone': '203-785-4576', 'title': 'Anish A Sheth M.D', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Domperidone', 'description': 'Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastroparesis Cardinal Symptom Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Domperidone', 'description': 'Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily'}], 'timeFrame': 'upon study completion', 'reportingStatus': 'POSTED', 'populationDescription': 'Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Domperidone', 'description': 'Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Domperidone', 'description': 'Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age was not collected and summarized.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Age was not collected and summarized.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Enrolled subjects were unable to receive drug from dispensing pharmacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2008-09-24', 'resultsFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-17', 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroparesis Cardinal Symptom Index', 'timeFrame': 'upon study completion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Age 18 and older\n* Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.\n* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.\n* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:\n\n * Increased prolactin levels\n * Breast changes\n * Extrapyramidal side effects\n * Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)\n\nExclusion Criteria:\n\n* History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.\n* Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\\>450 milliseconds for males, QTc\\>470 milliseconds for females)\n* Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.\n* Gastrointestinal hemorrhage or obstruction.\n* Presence of a prolactinoma (prolactin-releasing pituitary tumor).\n* Pregnant or breast feedings female.\n* Known allergy to domperidone'}, 'identificationModule': {'nctId': 'NCT00760461', 'briefTitle': 'Domperidone in Refractory Gastroparesis', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Domperidone in Refractory Gastroparesis', 'orgStudyIdInfo': {'id': '0809004202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Domperidone', 'interventionNames': ['Drug: Domperidone']}], 'interventions': [{'name': 'Domperidone', 'type': 'DRUG', 'description': '10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily', 'armGroupLabels': ['Domperidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Digestive Diseases 40 Temple St, Suite 1A', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Anish A Sheth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}