Back to resultsFour-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Primary Purpose
Non-erosive Reflux Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Non-erosive Reflux Disease
Eligibility Criteria
Inclusion Criteria: Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Exclusion Criteria: Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study
Sites / Locations
Outcomes
Primary Outcome Measures
To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.
Secondary Outcome Measures
Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.
Full Information
NCT ID
NCT00259077
First Posted
November 25, 2005
Last Updated
January 21, 2011
Sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00259077
Brief Title
Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Official Title
A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg od for the Four-week Treatment of Non-erosive Reflux Disease (NERD) With That of Placebo od and to Investigate Safety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Primary Outcome Measure Information:
Title
To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.
Secondary Outcome Measure Information:
Title
Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy.
Exclusion Criteria:
Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
City
Asa
Country
Japan
City
Beppu
Country
Japan
City
Chiyoda
Country
Japan
City
Fujieda
Country
Japan
City
Fukuoka
Country
Japan
City
Kanagawa
Country
Japan
City
Kawagucki
Country
Japan
City
Kitakyushu
Country
Japan
City
Kita
Country
Japan
City
Kyota
Country
Japan
City
Meguro
Country
Japan
City
Minato
Country
Japan
City
Mitsukaido
Country
Japan
City
Mizumaki
Country
Japan
City
Nagoya
Country
Japan
City
Nanao
Country
Japan
City
Onoda
Country
Japan
City
Osaka
Country
Japan
City
Ota
Country
Japan
City
Otsu
Country
Japan
City
Sapporo
Country
Japan
City
Shinagawa
Country
Japan
City
Shinjuku
Country
Japan
City
Tokyo
Country
Japan
City
Ube
Country
Japan
City
Yukuhashi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
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