This trial is active, not recruiting.

Conditions functional dyspepsia, helicobacter pylori infection
Treatment lansoprzole+amoxicillin+clarithromycin
Phase phase 4
Sponsor Korean College of Helicobacter and Upper Gastrointestinal Research
Start date October 2009
End date September 2010
Trial size 400 participants
Trial identifier NCT00990405, KoreanCHUGR05


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Primary Outcomes

Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
time frame: Symptom assessment at 8 weeks after eradication

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Phase 4 Study of Helicobacter Pylori Eradication Therapy
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Korean College of Helicobacter and Upper Gastrointestinal Research.