- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00634114
Reflux Esophagitis Phase III Study (Maintenance Treatment)
May 18, 2010 updated by: AstraZeneca
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
540
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Akita, Japan
- Research Site
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Fukuoka, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Oita, Japan
- Research Site
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Shizuoka, Japan
- Research Site
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Tottori, Japan
- Research Site
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Chiba
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Kashiwa, Chiba, Japan
- Research Site
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Kisarazu, Chiba, Japan
- Research Site
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Fukishima
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Koriyama, Fukishima, Japan
- Research Site
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Nihonmatsu, Fukishima, Japan
- Research Site
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Nishishirakawa, Fukishima, Japan
- Research Site
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Fukuoka
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Fukuoika, Fukuoka, Japan
- Research Site
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Kurume, Fukuoka, Japan
- Research Site
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Nukaya, Fukuoka, Japan
- Research Site
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Fukuolka
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Fukuoka, Fukuolka, Japan
- Research Site
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Fukushima
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Koriyama, Fukushima, Japan
- Research Site
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Shirakawa, Fukushima, Japan
- Research Site
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Sugawa, Fukushima, Japan
- Research Site
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Gifu
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Gifu-shi, Gifu, Japan
- Research Site
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Gunma
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Maebashi, Gunma, Japan
- Research Site
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Yasunaka, Gunma, Japan
- Research Site
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Hokkaido
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Sapporo, Hokkaido, Japan
- Research Site
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Ibaraki
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Hitachi, Ibaraki, Japan
- Research Site
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Mito, Ibaraki, Japan
- Research Site
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Tsukuba, Ibaraki, Japan
- Research Site
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Kagawa
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Sakaide, Kagawa, Japan
- Research Site
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Takamatsu, Kagawa, Japan
- Research Site
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Kanagawa
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Fujisawa, Kanagawa, Japan
- Research Site
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Kawasaki, Kanagawa, Japan
- Research Site
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Sagamihara, Kanagawa, Japan
- Research Site
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Yokohama, Kanagawa, Japan
- Research Site
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Myagi
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Shibata, Myagi, Japan
- Research Site
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Nagano
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Kiso, Nagano, Japan
- Research Site
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Matsumoto, Nagano, Japan
- Research Site
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Osaka
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Fujiidera, Osaka, Japan
- Research Site
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Toyonaka, Osaka, Japan
- Research Site
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Tochigi
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Ohtawara, Tochigi, Japan
- Research Site
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Tokayo
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Toshima-ku, Tokayo, Japan
- Research Site
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Tokyo
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Adachi, Tokyo, Japan
- Research Site
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Hachioji, Tokyo, Japan
- Research Site
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Kiyose, Tokyo, Japan
- Research Site
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Setagaya, Tokyo, Japan
- Research Site
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Shinagawa, Tokyo, Japan
- Research Site
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Yamaguchi
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Shimonoseki, Yamaguchi, Japan
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Esomeprazole and Omeprazole
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10mg once daily oral administration
Other Names:
20mg once daily oral administration
Other Names:
10mg once daily oral administration
Other Names:
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Experimental: 2
Esomeprazole
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10mg once daily oral administration
Other Names:
20mg once daily oral administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
Time Frame: Up to 24 weeks
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Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D).
A patient classfied into Grade O was considered no reflux esophagitis.
The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised.
Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
Time Frame: up to 4 weeks
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Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D).
A patient classfied into Grade O was considered no reflux esophagitis.
The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised.
Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
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up to 4 weeks
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Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Time Frame: Up to 12 weeks
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Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D).
A patient classfied into Grade O was considered no reflux esophagitis.
The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised.
Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
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Up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 4, 2008
First Submitted That Met QC Criteria
March 5, 2008
First Posted (Estimate)
March 12, 2008
Study Record Updates
Last Update Posted (Estimate)
June 17, 2010
Last Update Submitted That Met QC Criteria
May 18, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Esophagitis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Omeprazole
- Esomeprazole
Other Study ID Numbers
- D961HC00006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Reflux Esophagitis
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-
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Clinical Trials on Esomeprazole
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TakedaCompletedHealthy ParticipantsUnited States
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AstraZenecaCompletedRefractory Reflux EsophagitisJapan
-
Chinese University of Hong KongCompletedBleeding | Peptic UlcerChina
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Bio-innova Co., LtdNot yet recruiting
-
Onconic Therapeutics Inc.Completed
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Bio-innova Co., LtdNot yet recruiting
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Chong Kun Dang PharmaceuticalCompleted
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AstraZenecaCompletedGastroesophageal Reflux Disease (GERD)United States, France, Poland, Germany
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Chinese University of Hong KongTerminatedGastrointestinal HemorrhageChina