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Sponsors and Collaborators: |
AstraZeneca Mitsubishi Tanabe Pharma Corporation |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00259077 |
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.
Condition | Intervention | Phase |
---|---|---|
Non-Erosive Reflux Disease |
Drug: Omeprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 270 |
Study Start Date: | October 2003 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
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 | |
Mitsukaido, Japan | |
Chiyoda, Japan | |
Fujieda, Japan | |
Fukuoka, Japan | |
Sapporo, Japan | |
Kanagawa, Japan | |
Mizumaki, Japan | |
Shinjuku, Japan | |
Kawagucki, Japan | |
Shinagawa, Japan | |
yukuhashi, Japan | |
Kitakyushu, Japan | |
Nagoya, Japan |
Study Director: | AstraZeneca Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D9584L00002, D9587C00001 |
Study First Received: | November 25, 2005 |
Last Updated: | November 25, 2005 |
ClinicalTrials.gov Identifier: | NCT00259077 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Omeprazole |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |