Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
504
To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk
Time frame: Assessments at Week 0, Week 4, Week 12, Week 26
Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy.
Time frame: Assessments at Week 0, Week 4, Week 12, Week 26
Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy
Time frame: Assessments at Week 0, Week 4, Week 12, Week 26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.