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

Phase 3

Completed

• Conditions: NSAID Associated Gastric Ulcers
• Interventions: Drug: Esomeprazole; Drug: Ranitidine

• Registration Number: NCT00633672
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
2. Other key inclusion criteria, as specified in the protocol.

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Exclusion Criteria

1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other conditions and criteria, as specified in the protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole	20mg Oral tablet daily
2	Esomeprazole	40mg oral tablet daily
3	Ranitidine	150mg oral twice daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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