CompletedPhase 3

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

420 participantsStarted 2007-09

Plain-language summary

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or non-pregnant, non-breastfeeding female subjects with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 6 months, who were
✓. Female subjects were eligible for participation in the study if they were of
✓. Each subject was required to understand and comply with study procedures required of a subject and was 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 they were to have participated 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 they were to have participated in the study
✕. Schizophrenia or bipolar disorder
✕. Use of any excluded concomitant medication (see Section 9.4.8)

What they're measuring

Number of Participants With Gastric Ulcer Confirmed by Endoscopy

Timeframe: 6 months

Trial details

NCT IDNCT01129011

SponsorPOZEN

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09

Results submitted2010-05-27

View on ClinicalTrials.gov More Gastric Ulcer trials