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

Phase 4

• Conditions: Functional Dyspepsia; Helicobacter Pylori Infection
• Interventions: Drug: Lansoprzole+Amoxicillin+Clarithromycin

• Registration Number: NCT00990405
• Lead Sponsor: Korean College of Helicobacter and Upper Gastrointestinal Research

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

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Last Update Submitted: 2009-10-05
• Study First Posted: 2009-10-06
• Last Update Posted: 2009-10-06
• Primary Completion: 2010-09
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lansoprazole+Clarithromycin+Amoxycillin	Lansoprzole+Amoxicillin+Clarithromycin	Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Primary Outcome Measures

Name	Time	Method
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)	Symptom assessment at 8 weeks after eradication

Secondary Outcome Measures

Name	Time	Method
To improves the quality of life	1 year
Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy	1 year
The improvement of 8 dyspeptic symptom	1 year
The adequate relief of symptom	1 year

Trial Locations

Locations (1)

Korean Society of Helicobacter and Upper GI Research; 🇰🇷 Seoul, Korea, Republic of