Four-Week Omeprazole Treatment of Non-Erosive Reflux Disease in a Japanese Population
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Erosive Reflux Disease
Intervention: Omeprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in
a Japanese non-erosive reflux disease population.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Asa, Japan
Ota, Japan
Ube, Japan
Kita, Japan
Otsu, Japan
Beppu, Japan
Kyota, Japan
Nanao, Japan
Onoda, Japan
Osaka, Japan
Tokyo, Japan
Meguro, Japan
Minato, Japan
Nagoya, Japan
Chiyoda, Japan
Fujieda, Japan
Fukuoka, Japan
Sapporo, Japan
Kanagawa, Japan
Mizumaki, Japan
Shinjuku, Japan
Kawagucki, Japan
Shinagawa, Japan
yukuhashi, Japan
Kitakyushu, Japan
Mitsukaido, Japan
Additional Information
Starting date: October 2003
Last updated: November 25, 2005
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