Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Korean College of Helicobacter and Upper Gastrointestinal Research.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Korean College of Helicobacter and Upper Gastrointestinal Research
ClinicalTrials.gov Identifier:
NCT00990405
First received: October 5, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 5, 2009
October 5, 2009
October 2009
September 2010   (final data collection date for primary outcome measure)
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy) [ Time Frame: Symptom assessment at 8 weeks after eradication ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • To improves the quality of life [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The improvement of 8 dyspeptic symptom [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The adequate relief of symptom [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Functional Dyspepsia
  • Helicobacter Pylori Infection
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
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
Intervention: Drug: Lansoprzole+Amoxicillin+Clarithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00990405
KoreanCHUGR05
Yes
Seol, Sang-Young/President, Korean Society of Helicobacter and Upper Gastrointestinal Research
Korean College of Helicobacter and Upper Gastrointestinal Research
Not Provided
Study Chair: Sang-Young Seol, Professor Korean Society of Helicobacter and Upper Gastrointestinal Research
Korean College of Helicobacter and Upper Gastrointestinal Research
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP