A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

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 treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

Official Title
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A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

Conditions
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NSAID Associated Gastric Ulcers

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Ranitidine
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months. Other key inclusion criteria, as specified in the protocol. Exclusion Criteria: History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. Other conditions and criteria, as specified in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years


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: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20mg Oral tablet daily | Drug: Esomeprazole<br>* 20mg Oral tablet once daily<br>* Other names: Nexium;|
| Experimental: 2<br>40mg oral tablet daily | Drug: Esomeprazole<br>* 40mg oral tablet once daily<br>* Other names: Nexium;|
| Active Comparator: 3<br>150mg oral twice daily | Drug: Ranitidine<br>* 150mg oral twice daily<br>* Other names: Zantac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and investigator assessed GI symptoms for up to 8 weeks of treatment. |  | Assessments at week 0, week 4 and week 8 | 
| Safety and tolerability of the treatments for 8 weeks of treatment. |  | Assessments at week 0, week 4 and week 8 | 

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