At a glance
ClinicalIndex Comparison Record- ✓Age 18-49 with history of documented uncomplicated gastric or duodenal ulcer within past 5 years, OR age ≥50 (without prior ulcer requirement)
- ✓Condition requiring daily NSAID therapy for at least 12 months (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis)
- ✓Female subjects: non-childbearing potential OR childbearing potential with negative pregnancy test and appropriate contraception
- ✕Hypersensitivity to esomeprazole or other PPI
- ✕Allergic reaction or intolerance to any NSAID (including aspirin) or NSAID-induced asthma, rhinitis, or nasal polyps
- ✕Participation in investigational treatment study within 4 weeks before screening
- ✕Uncontrolled acute or chronic medical illness (GI disorder, hypertension, diabetes, thyroid disorder, depression, infection)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 in Subjects Who Are at Risk for Developing NSAID-associated Ulcers
In Brief
A Phase 3 clinical trial evaluating PN400 (VIMOVO) and PN 400 (VIMOVO) for Gastric Ulcer. Completed, enrolled 239 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
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.
500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months