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

NSAID Associated Gastric Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633672
• Other study ID #: SH-NEN-0006
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2008
• Last updated: January 24, 2011
• Start date: February 2001
• Est. completion date: October 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

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

Related Conditions & MeSH terms

• NSAID Associated Gastric Ulcers
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Esomeprazole
20mg Oral tablet once daily
• Ranitidine
150mg oral twice daily
• Esomeprazole
40mg oral tablet once daily

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 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	Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.		Assessments at week 0, week 4 and week 8
Secondary	Safety and tolerability of the treatments for 8 weeks of treatment.		Assessments at week 0, week 4 and week 8