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
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: October 2003
Intervention(s) in this Clinical Trial
- Drug: Esomeprazole
- 20mg Oral tablet once daily
- Drug: Ranitidine
- 150mg oral twice daily
- Drug: Esomeprazole
- 40mg oral tablet once daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 20mg Oral tablet daily
- Experimental: 2
- 40mg oral tablet daily
- Active Comparator: 3
- 150mg oral twice daily
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
- Time Frame: Assessments at week 0, week 4 and week 8
- Time Frame: Assessments at week 0, week 4 and week 8
- Safety and tolerability of the treatments for 8 weeks of treatment.
- Time Frame: Assessments at week 0, week 4 and week 8
- Time Frame: Assessments at week 0, week 4 and week 8
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633672
Study ID Number: SH-NEN-0006
ClinicalTrials.gov Identifier: NCT00633672
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00633672
