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 theefficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
276
To assess the efficacy of esomeprazole versus placebo through 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use
To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.
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Research Site
Tallassee, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Garden Grove, California, United States
Research Site
Orange, California, United States
Research Site
Bradenton, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Tavares, Florida, United States
Research Site
Zephyrhills, Florida, United States
...and 126 more locations