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

NCT ID: NCT00259077

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-07-31

Brief Summary

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The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.

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Detailed Description

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Conditions

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Non-erosive Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Omeprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Asa, , Japan

Site Status

Beppu, , Japan

Site Status

Chiyoda City, , Japan

Site Status

Fujieda, , Japan

Site Status

Fukuoka, , Japan

Site Status

Kanagawa, , Japan

Site Status

Kawagucki, , Japan

Site Status

Kita-ku, , Japan

Site Status

Kitakyushu, , Japan

Site Status

Kyoda, , Japan

Site Status

Meguro City, , Japan

Site Status

Minato, , Japan

Site Status

Mitsukaidō, , Japan

Site Status

Miyaodai, , Japan

Site Status

Nagoya, , Japan

Site Status

Nanao, , Japan

Site Status

Onoda, , Japan

Site Status

Osaka, , Japan

Site Status

Ōta-ku, , Japan

Site Status

Ōtsu, , Japan

Site Status

Sapporo, , Japan

Site Status

Shinagawa City, , Japan

Site Status

Shinjuku, , Japan

Site Status

Tokyo, , Japan

Site Status

Ube, , Japan

Site Status

Yukuhashi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D9584L00002

Identifier Type: -

Identifier Source: secondary_id

D9587C00001

Identifier Type: -

Identifier Source: org_study_id

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