Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis

Inclusion Criteria

• Male or non-pregnant female subjects50 years of age and older with a 6-month history of OA of the knee
• 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.
• 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 Current oral analgesic therapy was withdrawn at Screening.
• 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.
• Subjects were required to agree to keep physical activity at a stable level throughout the study.
• Subjects were required to have symptomatic OA of the knee meeting American College of Rheumatology (ACR) criteria for clinical diagnosis of OA.
• 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

• Subjects with rheumatoid arthritis or gout/pseudo-gout
• Subjects with fibromyalgia syndrome
• Acute joint trauma at the index joint within the 3 months prior to screen with active symptoms
• Previous (in the past 12 months) or anticipated need for surgical or invasive procedure performed on the index joint during the study
• Subject was currently taking or anticipated to take Coumadin®, warfarin, or lithium
• History of hypersensitivity to esomeprazole or to another PPI
• 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
• History of allergic reactions to sulfonamides
• Subjects with intra-articular or intramuscular corticosteroids or intra-articular hyaluronic acid injections within 8 weeks prior to randomization
• Participation in any study of an investigational treatment in the 4 weeks before Screening
• 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
• GI disorder (e.g., severe erosive esophagitis, Zollinger Ellison syndrome) or surgery leading to impaired drug absorption
• Peptic ulcer disease within 6 months prior to Screening
• 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
• Schizophrenia or bipolar disorder
• Subjects who had started physical therapy on the index joint less than 6 weeks prior to study Screening
• Use of any excluded concomitant medication
• 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
• Serious blood coagulation disorder including use of systemic anti-coagulants
• Screening laboratory value for alanine aminotransferase, aspartate aminotransferase greater than 2 times the upper limit of normal
• Estimated creatinine clearance less than 30 ml/min
• 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
• 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
• Previous participation in another PN 400 clinical research trial

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