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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Helicobacter Pylori Eradication Therapy

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 5, 2009
Last Updated: October 5, 2009
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
 Clarithromycin
Lansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013