Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT00272103
Status:
COMPLETED
Last Update Posted:
2006-05-04
First Post:
2006-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Itopride in Functional Dyspepsia:a Dose Finding Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C102254', 'term': 'itopride'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2002-01'}, 'lastUpdateSubmitDate': '2006-05-03', 'studyFirstSubmitDate': '2006-01-03', 'studyFirstSubmitQcDate': '2006-01-03', 'lastUpdatePostDateStruct': {'date': '2006-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'After 8 weeks of treatment:'}, {'measure': 'Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire)'}, {'measure': "Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)"}, {'measure': 'Improvement of pain and/or fullness by at least one grade on a 5-grade scale.'}], 'secondaryOutcomes': [{'measure': 'Safety parameters'}]}, 'conditionsModule': {'keywords': ['functional dyspepsia', 'non ulcer dyspepsia', 'drug treatment'], 'conditions': ['Functional Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '16495395', 'type': 'RESULT', 'citation': 'Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006 Feb 23;354(8):832-40. doi: 10.1056/NEJMoa052639.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia.\n\nThe study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms.', 'detailedDescription': "Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia.\n\nPatients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a) change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia Questionnaire), b) patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)and c) improvement of pain and/or fullness by at least one grade on a 5-grade scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of functional dyspepsia (Rome criteria) -\n\nExclusion Criteria:\n\nstructural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00272103', 'briefTitle': 'Itopride in Functional Dyspepsia:a Dose Finding Study', 'organization': {'class': 'OTHER', 'fullName': 'Royal Adelaide Hospital'}, 'officialTitle': 'A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Dose Finding Study in 4 Parallel Groups to Establish the Efficacy and Safety of an Eight Week Treatment With Itopride Three Times Daily Compared to Placebo in Patients Suffering From Functional Dyspepsia', 'orgStudyIdInfo': {'id': 'KD20003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Itopride (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45122', 'city': 'Essen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Hospital Essen'}], 'overallOfficials': [{'name': 'Gerald J Holtmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Adelaide Hospital, University of Adelaide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Adelaide Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Knoll Pharmaceuticals, Germany (now Abbott)', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Essen', 'class': 'OTHER'}]}}}