NCT00990405

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

Phase 4 Study of Helicobacter Pylori Eradication Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Korean College of Helicobacter and Upper Gastrointestinal Research · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Lansoprzole+Amoxicillin+Clarithromycin	Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2009-10-06
• Last updated: 2009-10-06

Locations

1 site across 1 country: South Korea