Conditions: Gastric Ulcer
Keywords: osteoarthritis rheumatoid arthritis ankylosing spondylisit NSAIDS
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 239
Healthy volunteers: no

Brief summary:
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).

Detailed description:
PN400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provide long-term safety data for PN400 in order to gain regulatory approval to make PN400 available for clinical use in this subject population.

Arms:
arm 1: 500 mg delayed release naproxen/20 mg immediate release esomeprazole

Interventions: intervention 1: PN400 (VIMOVO) intervention 2: PN 400 (VIMOVO)
Intervention descriptions: intervention 1: Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed. intervention 2: 500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months

Protocol document: