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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00990405
Date of registration: 05/10/2009
Primary sponsor: Korean College of Helicobacter and Upper Gastrointestinal Research
Public title: Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
Scientific title: Phase 4 Study of Helicobacter Pylori Eradication Therapy
Date of first enrolment: October 2009
Target sample size: 400
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Korea, Republic of
Name:   Sang-Young Seol, Professor
Affiliation:  Korean Society of Helicobacter and Upper Gastrointestinal Research
Key inclusion & exclusion criteria

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

Age minimum: 20 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Functional Dyspepsia
Helicobacter Pylori Infection
Drug: Lansoprzole+Amoxicillin+Clarithromycin
Primary Outcome(s)
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy) [Time Frame: Symptom assessment at 8 weeks after eradication]
Secondary Outcome(s)
Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy [Time Frame: 1 year]
The adequate relief of symptom [Time Frame: 1 year]
The improvement of 8 dyspeptic symptom [Time Frame: 1 year]
To improves the quality of life [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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