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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of Subjects Monitored for Long-term Safety of PN 400 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: PN 400 (VIMOVO)
500 mg delayed release naproxen/20 mg immediate release esomeprazole
Drug: PN400 (VIMOVO)
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.
Other Names:Drug: PN 400 (VIMOVO)
500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months
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.