Status:
COMPLETED
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Lead Sponsor:
AstraZeneca
Conditions:
NSAIDs
Upper GI Symptoms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo whe...
Eligibility Criteria
Inclusion
- Signed informed consent.
- 18 years of age, or older.
- Capable of completing the diary card.
- Ability to complete the HRQL questionnaires.
- A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (\>325 mg/day).
- Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)
- Hp negative by UBT, serology or biopsy based test, at visit 1.
Exclusion
- Current, or history of, gastric or duodenal ulcer
- Current, or history of, esophageal, gastric or duodenal surgery.
- History of GERD, not associated with NSAID use.
- Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
- Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
- Endoscopic Barrett's esophagus(\>3 cm) or significant dysplastic changes in the esophagus.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT00241527
Start Date
December 1 2000
End Date
September 1 2002
Last Update
January 24 2011
Active Locations (130)
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1
Research Site
Tallassee, Alabama, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Garden Grove, California, United States
4
Research Site
Orange, California, United States