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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: POZEN
• Treatments: Antacids; Anti-Ulcer Agents; Celecoxib

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 Current oral analgesic therapy was withdrawn at Screening.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