Ulcer Prevention II

NSAID Associated Gastric Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629928
• Other study ID #: SH-NEN-0014
• Secondary ID: D9617C00014
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2008
• Last updated: January 24, 2011
• Start date: February 2001
• Est. completion date: March 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. No active/current 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• NSAID Associated Gastric Ulcers
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Esomeprazole
20mg oral capsule daily
• Esomeprazole
40mg oral capsule daily
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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
Secondary	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