A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intraesophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg od in Patients With Non-erosive Reflux Disease (NERD).
2 other identifiers
interventional
40
1 country
13
Brief Summary
The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n 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 below P25 for phase_3
Started Jan 2004
Shorter than P25 for phase_3
13 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
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 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
7 months
November 25, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours.
Secondary Outcomes (1)
To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety
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. Written informed consent, ability to comply with study instructions
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 (13)
Research Site
Ashahikawa, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Ichihara, Japan
Research Site
Kochi, Japan
Research Site
Koshigaya, Japan
Research Site
Kurashiki, Japan
Research Site
Nakano City, Japan
Research Site
Nerima-ku, Japan
Research Site
Osaka, Japan
Research Site
Ōita, Japan
Research Site
Sapporo, Japan
Research Site
Yamato, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Japan Medical 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
January 1, 2004
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
January 24, 2011
Record last verified: 2011-01