Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-08 @ 2:34 AM
Study NCT ID:
NCT01226134
Status:
UNKNOWN
Last Update Posted:
2010-10-22
First Post:
2010-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C102254', 'term': 'itopride'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2010-10-21', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Functional Dyspepsia', 'Itopride', 'Gastric Emptying', 'Gastric Accommodation', 'Dyspeptic Symptoms'], 'conditions': ['Functional Dyspepsia', 'Gastric Emptying', 'Gastric Accommodation']}, 'descriptionModule': {'briefSummary': 'Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.\n\nPharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.\n\nItopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.\n\nThis study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients', 'detailedDescription': 'phase3 clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered\n2. Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.\n3. duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology\n4. A normal upper abdominal ultrasound\n5. Willing to participate and give consent for participation in the study.\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. Helicobacter Pylori positive on gastric biopsy and / or UBT.\n3. Taking other medications that alter gastric motility like macrolide\n\n * anti-emetics and antibiotics .\n4. Pregnant or breast-feeding females.'}, 'identificationModule': {'nctId': 'NCT01226134', 'acronym': 'EIGEAPFD', 'briefTitle': 'Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia', 'orgStudyIdInfo': {'id': '965-Med/ERC-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.Itopride Group', 'description': 'The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks', 'interventionNames': ['Drug: Itopride,']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2.Control placebo group', 'description': 'The control group will receive placebo tablets for four weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Itopride,', 'type': 'DRUG', 'otherNames': ['Gananton'], 'description': 'Itopride,50 mg capsules,thrice a day,for Four weeks', 'armGroupLabels': ['1.Itopride Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo capsules,thrice a day for four weeks', 'armGroupLabels': ['2.Control placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Shahab Abid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wasim Jafri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maseeh Uzzaman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rakhshanda Bilal', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Soobia Siddiqui, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Greger Lindberg, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Shahab Abid, MD', 'role': 'CONTACT', 'email': 'shahab.abid@aku.edu', 'phone': '+92 21 4864656', 'phoneExt': '4656'}, {'name': 'Wasim Jafri, MD', 'role': 'CONTACT', 'email': 'wasim.jafri@aku.edu', 'phone': '+92 21 4864659', 'phoneExt': '4659'}], 'overallOfficials': [{'name': 'Shahab Abid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Shahab Abid', 'oldOrganization': 'Aga Khan University,Karachi, Pakistan'}}}}