Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-24 @ 8:05 AM
Study NCT ID:
NCT00990405
Status:
UNKNOWN
Last Update Posted:
2009-10-06
First Post:
2009-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-05', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)', 'timeFrame': 'Symptom assessment at 8 weeks after eradication'}], 'secondaryOutcomes': [{'measure': 'To improves the quality of life', 'timeFrame': '1 year'}, {'measure': 'Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy', 'timeFrame': '1 year'}, {'measure': 'The improvement of 8 dyspeptic symptom', 'timeFrame': '1 year'}, {'measure': 'The adequate relief of symptom', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rome III criteria'], 'conditions': ['Functional Dyspepsia', 'Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia.\n\nThe investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.', 'detailedDescription': 'Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functional dyspepsia by Rome III criteria\n* Normal endoscopic findings\n* H. pylori positive by Urea breath test\n\nExclusion Criteria:\n\n* Patients with severe concomitant systemic disease\n* Patients with GI surgery\n* Females with pregnancy or breast-feeding\n* Irritable bowel syndrome, inflammatory bowel disease\n* Duodenal Ulcer, Gastric Ulcer, GI bleeding\n* History of eradication therapy of Helicobacter pylori\n* Malignancy\n* Psychosomatic disease'}, 'identificationModule': {'nctId': 'NCT00990405', 'briefTitle': 'Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Korean College of Helicobacter and Upper Gastrointestinal Research'}, 'officialTitle': 'Phase 4 Study of Helicobacter Pylori Eradication Therapy', 'orgStudyIdInfo': {'id': 'KoreanCHUGR05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lansoprazole+Clarithromycin+Amoxycillin', 'description': 'Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days', 'interventionNames': ['Drug: Lansoprzole+Amoxicillin+Clarithromycin']}], 'interventions': [{'name': 'Lansoprzole+Amoxicillin+Clarithromycin', 'type': 'DRUG', 'description': 'Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days', 'armGroupLabels': ['Lansoprazole+Clarithromycin+Amoxycillin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-87', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korean Society of Helicobacter and Upper GI Research', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sang-Young Seol, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Korean Society of Helicobacter and Upper Gastrointestinal Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean College of Helicobacter and Upper Gastrointestinal Research', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seol, Sang-Young/President', 'oldOrganization': 'Korean Society of Helicobacter and Upper Gastrointestinal Research'}}}}