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 in Subjects in the US Only

Phase 3

Completed

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

• Registration Number: NCT00633412
• 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 for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study Completion: 2003-03
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-09
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
• A gastric ulcer >= 5mm in diameter, but no ulcer >25 mm at its greatest diameter, at the baseline endoscopy.
• Other key inclusion criteria, as specified in the protocol.

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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.
• Many 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
The proportion of patients with no gastric ulcers after 8 weeks of treatment.	Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.

Secondary Outcome Measures

Name	Time	Method
The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N	Assessments at Week 0, Week 4 and Week 8
To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.	Assessments at Week 0, Week 4 and Week 8