Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia

NCT ID: NCT00990405

Last Updated: 2009-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.

Detailed Description

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

Conditions

Functional Dyspepsia; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lansoprazole+Clarithromycin+Amoxycillin

Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Group Type: EXPERIMENTAL

Lansoprzole+Amoxicillin+Clarithromycin

Intervention Type: DRUG

Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Interventions

Lansoprzole+Amoxicillin+Clarithromycin

Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Functional dyspepsia by Rome III criteria
• Normal endoscopic findings
• H. pylori positive by Urea breath test

Exclusion Criteria

• Patients with severe concomitant systemic disease
• Patients with GI surgery
• Females with pregnancy or breast-feeding
• Irritable bowel syndrome, inflammatory bowel disease
• Duodenal Ulcer, Gastric Ulcer, GI bleeding
• History of eradication therapy of Helicobacter pylori
• Malignancy
• Psychosomatic disease

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean College of Helicobacter and Upper Gastrointestinal Research

OTHER

Sponsor Role: lead

Responsible Party

Korean Society of Helicobacter and Upper Gastrointestinal Research

Principal Investigators

Sang-Young Seol, Professor

Role: STUDY_CHAIR

Korean Society of Helicobacter and Upper Gastrointestinal Research

Locations

Korean Society of Helicobacter and Upper GI Research

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

KoreanCHUGR05

Identifier Type: -

Identifier Source: org_study_id