Reflux Esophagitis Phase III Study (Maintenance Treatment)

NCT ID: NCT00634114

Last Updated: 2010-06-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-05-31

Brief Summary

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The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.

Detailed Description

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Conditions

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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 and Omeprazole

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

10mg once daily oral administration

Omeprazole

Intervention Type DRUG

10mg once daily oral administration

2

Esomeprazole

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

20mg once daily oral administration

Interventions

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Esomeprazole

10mg once daily oral administration

Intervention Type DRUG

Esomeprazole

20mg once daily oral administration

Intervention Type DRUG

Omeprazole

10mg once daily oral administration

Intervention Type DRUG

Other Intervention Names

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Nexium Nexium Prilosec

Eligibility Criteria

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Inclusion Criteria

* Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002)
* Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI

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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Fukuoika, Fukuoka, 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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Fukuoka, Fukuolka, Japan

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Kōriyama, Fukushima, 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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D961HC00006

Identifier Type: -

Identifier Source: org_study_id

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