Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
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
2 other identifiers
interventional
270
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2003
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 25, 2005
CompletedFirst Posted
Study publicly available on registry
November 29, 2005
CompletedJanuary 24, 2011
January 1, 2011
9 months
November 25, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Tanabe Pharma Corporationcollaborator
Study Sites (26)
Unknown Facility
Asa, Japan
Unknown Facility
Beppu, Japan
Unknown Facility
Chiyoda City, Japan
Unknown Facility
Fujieda, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Kanagawa, Japan
Unknown Facility
Kawagucki, Japan
Unknown Facility
Kita-ku, Japan
Unknown Facility
Kitakyushu, Japan
Unknown Facility
Kyoda, Japan
Unknown Facility
Meguro City, Japan
Unknown Facility
Minato, Japan
Unknown Facility
Mitsukaidō, Japan
Unknown Facility
Miyaodai, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Nanao, Japan
Unknown Facility
Onoda, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Ōta-ku, Japan
Unknown Facility
Ōtsu, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Shinagawa City, Japan
Unknown Facility
Shinjuku, Japan
Unknown Facility
Tokyo, Japan
Unknown Facility
Ube, Japan
Unknown Facility
Yukuhashi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 25, 2005
First Posted
November 29, 2005
Study Start
October 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
January 24, 2011
Record last verified: 2011-01