Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

Phase 3

Completed

• Conditions: Non-erosive Reflux Disease

• Registration Number: NCT00259077
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.