Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-01 @ 9:00 PM
Study NCT ID:
NCT01631994
Status:
TERMINATED
Last Update Posted:
2023-04-11
First Post:
2012-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DFriedel@nyuwinthrop.org', 'phone': '(516) 663-2528', 'title': 'David Friedel, MD', 'organization': "NYU Winthrop Hospital, Dep't of Gastroenterology"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'No adverse events were collected for this study as it was terminated prior to the collection of data.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Dissolving Metoclopramide', 'description': "Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.\n\nmetoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'This is the control group that will only ingest the capsule during video capsule endoscopy.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastric Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Dissolving Metoclopramide', 'description': "Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.\n\nmetoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule."}, {'id': 'OG001', 'title': 'Control Group', 'description': 'This is the control group that will only ingest the capsule during video capsule endoscopy.'}], 'timeFrame': 'Day 1', 'description': 'Time for transit through small intestine.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected from the enrolled participants. Study was terminated prior to collection of data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Dissolving Metoclopramide', 'description': "Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.\n\nmetoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule."}, {'id': 'FG001', 'title': 'Control Group', 'description': 'This is the control group that will only ingest the capsule during video capsule endoscopy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was ended early, only 6 patients were enrolled, 2 to the research arm, 4 to the control arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Dissolving Metoclopramide', 'description': "Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.\n\nmetoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule."}, {'id': 'BG001', 'title': 'Control Group', 'description': 'This is the control group that will only ingest the capsule during video capsule endoscopy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '5', 'groupId': 'BG000'}, {'value': '40', 'spread': '5', 'groupId': 'BG001'}, {'value': '40', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'No support to run the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2012-06-24', 'resultsFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-17', 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric Transit Time', 'timeFrame': 'Day 1', 'description': 'Time for transit through small intestine.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metoclopramide video capsule endoscopy gastric transit time'], 'conditions': ['Gastric Transit Time']}, 'descriptionModule': {'briefSummary': 'Summary:\n\nThis study investigates the use of oral dissolving metoclopramide during standard video capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps with movement through the stomach and small bowel. This study will help us determine the effectiveness of oral dissolving metoclopramide on transit time through the stomach and small bowel of the video capsule that is ingested. This study may help with better diagnoses of pathology in the small bowel. Each patient enrolled in the study will either be assigned to a group that only ingests the capsule or the group that receives the oral dissolving metoclopramide plus capsule. Each patient will undergo the same standard procedures and precaution used during standard video capsule endoscopy. The patients that will qualify for the study are patients that are in need of video capsule endoscopy for further imaging of the small bowel. The patients must meet the inclusion criteria provided in the protocol and must not meet any of the exclusion criteria in the protocol. The hypothesis is that the patients that ingest the metoclopramide will have better capsule images and transit time and will allow for enhanced diagnosis of small bowel pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients 18 years - 70 years old, male or female, belonging to any race or ethnic origin.\n2. Patients necessitating video capsule endoscopy.\n3. Patients who are willing and competent to sign an informed consent and to comply with study related visits and procedures.\n\nExclusion Criteria:\n\n1. Patients below the age of 18 or greater than 70 years old.\n2. Pregnant patients\n3. Patients with a documented history of Parkinson's Disease or Parkinsonian Symptoms, Tardive Dyskinesia, history of neuroleptic malignant syndrome, history or seizure disorder.\n4. Patients who are currently taking antipsychotic medications including typical and atypical antipsychotics.\n5. Patients taking other drugs that may cause extrapyramidal reactions.\n6. Patients with a history of cirrhosis or congestive heart failure.\n7. Patients with a history of depression.\n8. Patients with uncontrolled hypertension.\n9. Patients with renal impairment, creatinine clearance \\< 40ml/minute.\n10. Patients who have massive gastrointestinal hemorrhage, mechanical obstruction, or perforation.\n11. Patients with a known history of pheochromocytoma, as this may precipitate hypertensive crisis.\n12. Patients with a known sensitivity or intolerance to metoclopramide.\n13. Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study.\n14. Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest."}, 'identificationModule': {'nctId': 'NCT01631994', 'briefTitle': 'Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Winthrop University Hospital'}, 'officialTitle': 'A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.', 'orgStudyIdInfo': {'id': 'WUH 254286-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Dissolving metoclopramide', 'description': "Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.", 'interventionNames': ['Drug: metoclopramide']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'This is the control group that will only ingest the capsule during video capsule endoscopy.'}], 'interventions': [{'name': 'metoclopramide', 'type': 'DRUG', 'description': '1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.', 'armGroupLabels': ['Oral Dissolving metoclopramide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}], 'overallOfficials': [{'name': 'David Friedel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Winthrop University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}