Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
This study uses a randomized, double-blind, controlled design to demonstrate that PN400
(esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal
ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric
ulcers compared to naproxen alone.
A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)
This study uses an open-label design and will be conducted in approximately 60 sites aiming
to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12
months exposure to PN400 (VIMOVO).
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6
months duration is designed to assess the efficacy, tolerability and safety of PN400 versus
diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric
ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per
At least 20% of the subjects enrolled will be age 65 years and older.
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