We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Korean College of Helicobacter and Upper Gastrointestinal Research.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990405
First Posted: October 6, 2009
Last Update Posted: October 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korean College of Helicobacter and Upper Gastrointestinal Research
  Purpose

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.


Condition Intervention Phase
Functional Dyspepsia Helicobacter Pylori Infection Drug: Lansoprzole+Amoxicillin+Clarithromycin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Helicobacter Pylori Eradication Therapy

Resource links provided by NLM:


Further study details as provided by Korean College of Helicobacter and Upper Gastrointestinal Research:

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

Estimated Enrollment: 400
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990405


Locations
Korea, Republic of
Korean Society of Helicobacter and Upper GI Research
Seoul, Korea, Republic of, 135-87
Sponsors and Collaborators
Korean College of Helicobacter and Upper Gastrointestinal Research
Investigators
Study Chair: Sang-Young Seol, Professor Korean Society of Helicobacter and Upper Gastrointestinal Research
  More Information

Responsible Party: Seol, Sang-Young/President, Korean Society of Helicobacter and Upper Gastrointestinal Research
ClinicalTrials.gov Identifier: NCT00990405     History of Changes
Other Study ID Numbers: KoreanCHUGR05
First Submitted: October 5, 2009
First Posted: October 6, 2009
Last Update Posted: October 6, 2009
Last Verified: October 2009

Keywords provided by Korean College of Helicobacter and Upper Gastrointestinal Research:
Rome III criteria

Additional relevant MeSH terms:
Dyspepsia
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors