Status:
UNKNOWN
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
Lead Sponsor:
Korean College of Helicobacter and Upper Gastrointestinal Research
Conditions:
Functional Dyspepsia
Helicobacter Pylori Infection
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
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...
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: Sa...
Eligibility Criteria
Inclusion
- Functional dyspepsia by Rome III criteria
- Normal endoscopic findings
- H. pylori positive by Urea breath test
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00990405
Start Date
October 1 2009
End Date
December 1 2010
Last Update
October 6 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Korean Society of Helicobacter and Upper GI Research
Seoul, Seoul, South Korea, 135-87