Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
1 other identifier
interventional
343
1 country
39
Brief Summary
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2007
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 12, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
May 28, 2010
CompletedMay 28, 2010
May 1, 2010
October 11, 2007
February 16, 2010
May 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
The absence of gastric and/or duodenal ulcer throughout the treatment period
each visit up to 24 weeks
Secondary Outcomes (2)
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
up to 4 weeks
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
up to 12 weeks
Study Arms (2)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTALEsomeprazole 20 mg
Interventions
Eligibility Criteria
You may qualify if:
- Medical history of gastric and/or duodenal ulcer
- A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
You may not qualify if:
- Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
- History of esophageal, gastric or duodenal surgery
- Having severe liver disease or chronic renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (39)
Research Site
Chiryū, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Yotukaido, Chiba, Japan
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Miyaodai, Fukuoka, Japan
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Sapporo, Hokkaido, Japan
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Akashi, HYOGOi, Japan
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Itami, Hyōgo, Japan
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Koto, Hyōgo, Japan
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Nishinomiya, Hyōgo, Japan
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Hitachi, Ibaragi, Japan
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Morioka, Iwate, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kōtari, Kyoto, Japan
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Kyoto, Kyoto, Japan
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Chiisagata, Nagano, Japan
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Matsumoto, Nagano, Japan
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Nagano, Nagano, Japan
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Sasebo, Nagasaki, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Ibara, Okayama-ken, Japan
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Hirakata, Osaka, Japan
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Osaka, Osaka, Japan
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Sakai, Osaka, Japan
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Suita, Osaka, Japan
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Takatsuki, Osaka, Japan
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Kawagoe, Saitama, Japan
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Saitama, Saitama, Japan
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Fukuroi, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Maikinohara, Shizuoka, Japan
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Shizuoka, Shizuoka, Japan
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Yaizu, Shizuoka, Japan
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Shimotsuke, Tochigi, Japan
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Chiyoda City, Tokyo, Japan
Research Site
Koto, Tokyo, Japan
Research Site
Musashimurayama, Tokyo, Japan
Related Publications (1)
Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16.
PMID: 22591121DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Naotsugu Oyama
AstraZeneca Japan
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
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 12, 2007
Study Start
August 1, 2007
Study Completion
February 1, 2009
Last Updated
May 28, 2010
Results First Posted
May 28, 2010
Record last verified: 2010-05