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

Helicobacter Pylori Infection Clinical Trial

Official title:

Phase 4 Study of Helicobacter Pylori Eradication Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00990405
• Other study ID #: KoreanCHUGR05
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 5, 2009
• Last updated: October 5, 2009
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2009
• Source: Korean College of Helicobacter and Upper Gastrointestinal Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis
• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korean Society of Helicobacter and Upper GI Research	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean College of Helicobacter and Upper Gastrointestinal Research

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)		Symptom assessment at 8 weeks after eradication	Yes
Secondary	To improves the quality of life		1 year	Yes
Secondary	Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy		1 year	Yes
Secondary	The improvement of 8 dyspeptic symptom		1 year	Yes
Secondary	The adequate relief of symptom		1 year	Yes