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

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ClinicalTrials.gov Identifier: NCT00990405
Recruitment Status : Unknown
Verified October 2009 by Korean College of Helicobacter and Upper Gastrointestinal Research.
Recruitment status was:  Active, not recruiting
First Posted : October 6, 2009
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Korean College of Helicobacter and Upper Gastrointestinal Research

Brief 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.


Condition or disease Intervention/treatment Phase
Functional Dyspepsia Helicobacter Pylori Infection Drug: Lansoprzole+Amoxicillin+Clarithromycin Phase 4

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  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Study Start Date : October 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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



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


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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

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

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 Posted: October 6, 2009    Key Record Dates
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