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Sponsors and Collaborators: |
AstraZeneca Mitsubishi Tanabe Pharma Corporation |
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 |
MedlinePlus related topics: | Heartburn |
ChemIDplus related topics: | Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium |
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 |
AstraZeneca |
Mitsubishi Tanabe Pharma Corporation |
Study Director: | AstraZeneca Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D9584L00002, D9587C00001 |
First Received: | November 25, 2005 |
Last Updated: | November 25, 2005 |
ClinicalTrials.gov Identifier: | NCT00259077 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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