Back to resultsClinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
Primary Purpose
Functional Dyspepsia, Helicobacter Pylori Infection
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lansoprzole+Amoxicillin+Clarithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Rome III criteria
Eligibility 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
Sites / Locations
- Korean Society of Helicobacter and Upper GI Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lansoprazole+Clarithromycin+Amoxycillin
Arm Description
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
Outcomes
Primary Outcome Measures
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
Secondary Outcome Measures
To improves the quality of life
Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy
The improvement of 8 dyspeptic symptom
The adequate relief of symptom
Full Information
NCT ID
NCT00990405
First Posted
October 5, 2009
Last Updated
October 5, 2009
Sponsor
Korean College of Helicobacter and Upper Gastrointestinal Research
1. Study Identification
Unique Protocol Identification Number
NCT00990405
Brief Title
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
Official Title
Phase 4 Study of Helicobacter Pylori Eradication Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Korean College of Helicobacter and Upper Gastrointestinal Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Helicobacter Pylori Infection
Keywords
Rome III criteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lansoprazole+Clarithromycin+Amoxycillin
Arm Type
Experimental
Arm Description
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
Intervention Type
Drug
Intervention Name(s)
Lansoprzole+Amoxicillin+Clarithromycin
Intervention Description
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To improves the quality of life
Time Frame
1 year
Title
Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy
Time Frame
1 year
Title
The improvement of 8 dyspeptic symptom
Time Frame
1 year
Title
The adequate relief of symptom
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Young Seol, Professor
Organizational Affiliation
Korean Society of Helicobacter and Upper Gastrointestinal Research
Official's Role
Study Chair
Facility Information:
Facility Name
Korean Society of Helicobacter and Upper GI Research
City
Seoul
ZIP/Postal Code
135-87
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
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