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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
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).
Details
| Lead sponsor | POZEN |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 239 |
| Start date | 2007-03 |
| Completion | 2009-03 |
Conditions
- Gastric Ulcer
Interventions
- PN400 (VIMOVO)
- PN 400 (VIMOVO)
Primary outcomes
- Number of Subjects Monitored for Long-term Safety of PN 400 — 12 months
Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.
Countries
United States