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Reflux Esophagitis Phase III Study (Initial Treatment)

NCT ID: NCT00633932

Last Updated: 2010-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Detailed Description

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Conditions

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Reflux Esophagitis

Keywords

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Reflux Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Esomeprazole 20mg

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

20mg once daily

2

Esomeprazole 40mg

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40 mg once daily

3

Omeprazole 20mg

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

20mg once daily

Interventions

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Esomeprazole

20mg once daily

Intervention Type DRUG

Esomeprazole

40 mg once daily

Intervention Type DRUG

Omeprazole

20mg once daily

Intervention Type DRUG

Other Intervention Names

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Nexium Nexium Prilosec

Eligibility Criteria

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Inclusion Criteria

* Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

Exclusion Criteria

* Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
* Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Maotsugu Oyama, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Akita, Akita, Japan

Site Status

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Kashiwa, Chiba, Japan

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Kisarazu, Chiba, Japan

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Kōriyama, Fukishima, Japan

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Nihonmatsu, Fukishima, Japan

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Nishishirakawa, Fukishima, Japan

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Fukuoka, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Nukaya, Fukuoka, Japan

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Shirakawa, Fukushima, Japan

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Sugawa, Fukushima, Japan

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Gifu, Gifu, Japan

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Maebashi, Gunma, Japan

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Yasunaka, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Hitachi, Ibaraki, Japan

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Mito, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Sakaidechō, Kagawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Fujisawa, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kyoto, Kyoto, Japan

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Shibata, Myagi, Japan

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Kiso, Nagano, Japan

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Matsumoto, Nagano, Japan

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Ōita, Oita Prefecture, Japan

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Fujiidera, Osaka, Japan

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Toyonaka, Osaka, Japan

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Shizuoka, Shizuoka, Japan

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Ohtawara, Tochigi, Japan

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Toshima-ku, Tokayo, Japan

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Adachi City, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Kiyose, Tokyo, Japan

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Setagaya City, Tokyo, Japan

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Shinagawa, Tokyo, Japan

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Tottori-shi, Tottori, Japan

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Shimonoseki, Yamaguchi, Japan

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Countries

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Japan

Other Identifiers

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D961HC00002

Identifier Type: -

Identifier Source: org_study_id