Ulcer Prevention II

Study Overview
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Brief Summary
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Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

Official Title
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A Comparative Efficacy and Safety of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric and Duodenal Ulcers Associated With Daily NSAID Use in Patients at Risk

Conditions
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NSAID Associated Gastric Ulcers

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No active/current gastric or duodenal ulcer on baseline endoscopy. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months. Other inclusion criteria, as defined in the protocol. Exclusion Criteria: 1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer. 2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. 3. Other criteria, as defined in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20mg capsule once daily | Drug: Esomeprazole<br>* 20mg oral capsule daily<br>* Other names: Nexium;|
| Experimental: 2<br>40mg capsule daily | Drug: Esomeprazole<br>* 40mg oral capsule daily<br>* Other names: Nexium;|
| Placebo Comparator: 3<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy. |  | Assessments at Week 0, Week 4, Week 12, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo in patients receiving daily NSAID therapy. |  | Assessments at Week 0, Week 4, Week 12, Week 26 | 
| Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy. |  | Assessments at Week 0, Week 4, Week 12, Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAID, Nexium, esomeprazole, Gastric Ulcers