CompletedPhase 3

A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)

United States239 participantsStarted 2007-03

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or non-pregnant female subjects with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months:
✓. Female subjects were eligible for participation in the study if they were of
✓. Each subject was required to be able and willing to provide written informed consent prior to any study procedures being performed.

Exclusion criteria

✕. History of hypersensitivity to esomeprazole or to another PPI
✕. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
✕. Participation in any study of an investigational treatment in the 4 weeks before Screening
✕. Presence of uncontrolled acute or chronic medical illness, e.g., GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would have endangered a subject if he/she were to participate in the study
✕. GI disorder or surgery leading to impaired drug absorption
✕. Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder which in the investigator's opinion would have endangered a subject if he/she were to participate in the study
✕. Schizophrenia or bipolar disorder
✕. Use of any excluded concomitant medication

What they're measuring

Number of Subjects Monitored for Long-term Safety of PN 400

Timeframe: 12 months

Trial details

NCT IDNCT00527904

SponsorPOZEN

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2010-05-28

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