Reflux Esophagitis Phase III Study (Initial Treatment)
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis
1 other identifier
interventional
602
1 country
41
Brief Summary
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Shorter than P25 for phase_3
41 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
December 1, 2007
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
December 1, 2008
CompletedResults Posted
Study results publicly available
April 8, 2010
CompletedDecember 20, 2010
December 1, 2010
March 4, 2008
December 10, 2009
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference).
8 weeks
Secondary Outcomes (1)
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
4 weeks
Study Arms (3)
1
EXPERIMENTALEsomeprazole 20mg
2
EXPERIMENTALEsomeprazole 40mg
3
ACTIVE COMPARATOROmeprazole 20mg
Interventions
Eligibility Criteria
You may qualify if:
- Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation
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 (41)
Research Site
Akita, Akita, Japan
Research Site
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
Research Site
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
December 1, 2007
Study Completion
December 1, 2008
Last Updated
December 20, 2010
Results First Posted
April 8, 2010
Record last verified: 2010-12