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 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
334
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
prevention of relapse of upper GI symptom associated with NSAID use in patients
receiving daily NSAID therapy.
To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy.
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Research Site
Tucson, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Orange, California, United States
Research Site
San Francisco, California, United States
Research Site
Bradenton, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
West Palm Beach, Florida, United States
...and 103 more locations