Back to resultsComparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
Primary Purpose
Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Ulcer focused on measuring gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
Esomeprazole 20 mg
Outcomes
Primary Outcome Measures
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
The absence of gastric and/or duodenal ulcer throughout the treatment period
Secondary Outcome Measures
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542789
Brief Title
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
Keywords
gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
343 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Esomeprazole 20 mg
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg once daily oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily oral
Primary Outcome Measure Information:
Title
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Description
The absence of gastric and/or duodenal ulcer throughout the treatment period
Time Frame
each visit up to 24 weeks
Secondary Outcome Measure Information:
Title
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Description
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Time Frame
up to 4 weeks
Title
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Description
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naotsugu Oyama
Organizational Affiliation
AstraZeneca Japan
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Chiryu
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Yotukaido
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Mizumaki
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Akashi
State/Province
HYOGOi
Country
Japan
Facility Name
Research Site
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Koto
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Hitachi
State/Province
Ibaragi
Country
Japan
Facility Name
Research Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Research Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Nagaokakyo
State/Province
Kyoto
Country
Japan
Facility Name
Research Site
City
Chiisagata
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Sasebo
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Ihara
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Takatsuki
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Fukuroi
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Izunokuni
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Maikinohara
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Yaizu
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Research Site
City
Chiyoda
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Koto
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Musashimurayama
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Nagano
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Saitama
Country
Japan
Facility Name
Research Site
City
Shizuoka
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22591121
Citation
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.
Results Reference
derived
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Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
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