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

October 5, 2009 updated by: Korean College of Helicobacter and Upper Gastrointestinal Research

Phase 4 Study of Helicobacter Pylori Eradication Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-87
        • Korean Society of Helicobacter and Upper GI Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lansoprazole+Clarithromycin+Amoxycillin
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
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
Time Frame: Symptom assessment at 8 weeks after eradication
Symptom assessment at 8 weeks after eradication

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean College of Helicobacter and Upper Gastrointestinal Research

Investigators

  • Study Chair: Sang-Young Seol, Professor, Korean Society of Helicobacter and Upper Gastrointestinal Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 5, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KoreanCHUGR05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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