Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* once daily oral<br>|
| Experimental: 2<br>Esomeprazole 20 mg | Drug: Esomeprazole<br>* 20mg once daily oral<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 4 weeks | 
| 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 | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer