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

NCT00990405 | Unknown Phase 4 DMC

• 1 other identifier: KoreanCHUGR05
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; Helicobacter Pylori Infection

Keywords

Rome III criteria

Outcome Measures

Primary Outcomes (1)

• Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)

  Symptom assessment at 8 weeks after eradication

Secondary Outcomes (4)

• 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

Study Arms (1)

Lansoprazole+Clarithromycin+Amoxycillin

EXPERIMENTAL

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

Drug: Lansoprzole+Amoxicillin+Clarithromycin

Interventions

Lansoprzole+Amoxicillin+Clarithromycin DRUG

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

Lansoprazole+Clarithromycin+Amoxycillin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean College of Helicobacter and Upper Gastrointestinal Research: lead

Study Sites (1)

Korean Society of Helicobacter and Upper GI Research

Seoul, Seoul, 135-87, South Korea

Location

Study Officials

• Sang-Young Seol, Professor

  Korean Society of Helicobacter and Upper Gastrointestinal Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 6, 2009

Record last verified: 2009-10

Locations

KR (1)