Reflux Esophagitis Phase III Study (Maintenance Treatment)
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
1 other identifier
interventional
540
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2008
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 4, 2008
CompletedFirst Posted
Study publicly available on registry
March 12, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
June 17, 2010
CompletedJune 17, 2010
May 1, 2010
March 4, 2008
May 18, 2010
May 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
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.
Up to 24 weeks
Secondary Outcomes (2)
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
up to 4 weeks
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Up to 12 weeks
Study Arms (2)
1
EXPERIMENTALEsomeprazole and Omeprazole
2
EXPERIMENTALEsomeprazole
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (44)
Research Site
Akita, Akita, Japan
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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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Maotsugu Oyama, MD, PhD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2008
First Posted
March 12, 2008
Study Start
January 1, 2008
Study Completion
May 1, 2009
Last Updated
June 17, 2010
Results First Posted
June 17, 2010
Record last verified: 2010-05