Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec (NCT00594854) | Clinical Trial Compass
TerminatedPhase 3
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
Stopped: POZEN agreed with FDA to stop study due to low and inadequate enrollment
United States20 participantsStarted 2007-09
Plain-language summary
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm).
At least 20% of the subjects enrolled will be age 65 years and older.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant female subjects, 18 years and older with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical condition expected to require daily NSAID therapy for at least 6 months, with a documented history of an ulcer related serious upper gastrointestinal event such as bleeding, perforation or obstruction
✓. Female subjects are eligible for participation in the study if they are of:
✓. Each subject must be able to understand and comply with study procedures required of a subject and is 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 proton-pump inhibitor
✕. 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
✕. Positive test result for H. pylori at screening
✕. Participation in any study of an investigational treatment in the 4 weeks before screening
What they're measuring
1
Number of Participants With Gastric Ulcer Confirmed by Endoscopy
. Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
✕. Gastrointestinal disorder or surgery leading to impaired drug absorption
✕. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study