Prevention of Gastric Ulcers

Phase 3

Completed

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

• Registration Number: NCT00629512
• Lead Sponsor: AstraZeneca

Brief Summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention 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; versus placebo; in patients at risk.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

1. No gastric or duodenal ulcer on baseline endoscopy.
2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	Esomeprazole	20mg oral daily
2	Esomeprazole	40mg oral daily

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk	Assessments at Week 0, Week 4, Week 12, Week 26

Secondary Outcome Measures

Name	Time	Method
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 20mg 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 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy	Assessments at Week 0, Week 4, Week 12, Week 26