Status:
COMPLETED
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Lead Sponsor:
AstraZeneca
Conditions:
GERD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of eso...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
- A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
- Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and; Are expected to remain stable for the duration of the study. and; Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
- Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.
Exclusion
- Discontinuation from study SH-NEN-0001
- 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.
- Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
- Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
End Date :
February 1 2003
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00241514
Start Date
February 1 2001
End Date
February 1 2003
Last Update
January 21 2011
Active Locations (113)
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1
Research Site
Tucson, Arizona, United States
2
Research Site
Anaheim, California, United States
3
Research Site
Orange, California, United States
4
Research Site
San Francisco, California, United States