Back to resultsA 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
Primary Purpose
NSAID Associated Gastric Ulcers
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esomeprazole
Ranitidine
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for NSAID Associated Gastric Ulcers focused on measuring NSAID, Nexium, esomeprazole, Gastric Ulcers
Eligibility Criteria
Inclusion Criteria:
- A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- Other key inclusion criteria, as specified in the protocol.
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.
- Other conditions and criteria, as specified in the protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
20mg Oral tablet daily
40mg oral tablet daily
150mg oral twice daily
Outcomes
Primary Outcome 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 Outcome Measures
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Safety and tolerability of the treatments for 8 weeks of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00633672
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSAID Associated Gastric Ulcers
Keywords
NSAID, Nexium, esomeprazole, Gastric Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
20mg Oral tablet daily
Arm Title
2
Arm Type
Experimental
Arm Description
40mg oral tablet daily
Arm Title
3
Arm Type
Active Comparator
Arm Description
150mg oral twice daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg Oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Ranitidine
Other Intervention Name(s)
Zantac
Intervention Description
150mg oral twice daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg oral tablet once daily
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Time Frame
Assessments at week 0, week 4 and week 8
Title
Safety and tolerability of the treatments for 8 weeks of treatment.
Time Frame
Assessments at week 0, week 4 and week 8
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
Other key inclusion criteria, as specified in the protocol.
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.
Other conditions and criteria, as specified in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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