Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: PN 400 (VIMOVO); celebrex; Placebo; Rescue Antacid
Intervention description: 500 mg naproxen/20 mg esomeprazole bid; 200 mg celecoxib qd; sugar pill bid; Antacid Tablets
Intervention MeSH terms: Celecoxib; Antacids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 614.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      We will evaluate the efficacy of PN400 and an active comparator in patients that have
      Osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or non-pregnant female subjects50 years of age and older with a 6-month history
             of OA of the knee

          2. Female subjects were eligible for participation in the study if they were of
             non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or
             of childbearing potential, had a negative pregnancy test at Screening, and using
             adequate contraceptive methods.

          3. Subjects were required to have been on a stable dose of NSAIDs, COX-2 inhibitors or
             other oral analgesic therapy for at least 6 weeks and required to continue treatment
             for 12 weeks. Current oral analgesic therapy was withdrawn at Screening.

          4. Each subject was required to be able 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.

          5. Subjects were required to agree to keep physical activity at a stable level throughout
             the study.

          6. Subjects were required to have symptomatic OA of the knee meeting American College of
             Rheumatology (ACR) criteria for clinical diagnosis of OA.

          7. Subjects were required to have an ACR functional class rating of I, II or III. In
             addition, subjects meet the requirements for OA flare at the Baseline/ Randomization
             Visit.

        Exclusion Criteria

          1. Subjects with rheumatoid arthritis or gout/pseudo-gout

          2. Subjects with fibromyalgia syndrome

          3. Acute joint trauma at the index joint within the 3 months prior to screen with active
             symptoms

          4. Previous (in the past 12 months) or anticipated need for surgical or invasive
             procedure performed on the index joint during the study

          5. Subject was currently taking or anticipated to take Coumadin®, warfarin, or lithium

          6. History of hypersensitivity to esomeprazole or to another PPI

          7. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or
             subject had a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal
             polyps

          8. History of allergic reactions to sulfonamides

          9. Subjects with intra-articular or intramuscular corticosteroids or intra-articular
             hyaluronic acid injections within 8 weeks prior to randomization

         10. Participation in any study of an investigational treatment in the 4 weeks before
             Screening

         11. Presence of uncontrolled acute or chronic medical illness, e.g. morbid obesity, GI
             disorder, diabetes, active GI disease, chronic or acute renal or hepatic disorder,
             depression and/or infection, etc, that would endanger a subject if the subject were to
             participate in the study

         12. GI disorder (e.g., severe erosive esophagitis, Zollinger Ellison syndrome) or surgery
             leading to impaired drug absorption

         13. Peptic ulcer disease within 6 months prior to Screening

         14. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in
             the investigator's opinion would have endangered a subject if the subject were to
             participate in the study

         15. Schizophrenia or bipolar disorder

         16. Subjects who had started physical therapy on the index joint less than 6 weeks prior
             to study Screening

         17. Use of any excluded concomitant medication

         18. A recent history (in the past 3 months) suggestive of alcohol or drug abuse or
             dependence, including overuse/abuse of narcotics for management of pain

         19. Serious blood coagulation disorder including use of systemic anti-coagulants

         20. Screening laboratory value for alanine aminotransferase, aspartate aminotransferase
             greater than 2 times the upper limit of normal

         21. Estimated creatinine clearance less than 30 ml/min

         22. Other than noted specifically, any Screening laboratory value that was clinically
             significant in the investigator's opinion and would have endangered a subject if the
             subjects were to participate in the study

         23. History of malignancy, treated or untreated, within the past 5 years, with the
             exception of successfully treated basal cell or squamous cell carcinoma of the skin

         24. Previous participation in another PN 400 clinical research trial

         25. Subjects who were employees of the research facility or who were in some way under the
             supervision of the principal investigator for this study