Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
Overview[ - collapse ][ - ]
| Purpose | We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee. |
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| Condition | Osteoarthritis |
| Intervention | Drug: PN 400 (VIMOVO) Drug: celebrex Drug: Placebo Drug: Rescue Antacid |
| Phase | Phase 3 |
| Sponsor | POZEN |
| Responsible Party | POZEN |
| ClinicalTrials.gov Identifier | NCT00664560 |
| First Received | April 18, 2008 |
| Last Updated | January 20, 2012 |
| Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 18, 2008 |
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| Last Updated Date | January 20, 2012 |
| Start Date | April 2008 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis |
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| Official Title | Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee |
| Brief Summary | We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee. |
| Detailed Description | 3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Osteoarthritis |
| Intervention | Drug: PN 400 (VIMOVO) 500 mg naproxen/20 mg esomeprazole bid Other Names: PN 400Drug: celebrex 200 mg celecoxib qd Other Names: CelebrexDrug: Placebo sugar pill bid Other Names: placeboDrug: Rescue Antacid Antacid Tablets |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 614 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | December 2008 |
| 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 |
| Gender | Both |
| Ages | 50 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00664560 |
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| Other Study ID Numbers | PN400-307 |
| Has Data Monitoring Committee | No |
| Information Provided By | POZEN |
| Study Sponsor | POZEN |
| Collaborators | Not Provided |
| Investigators | Study Chair: Everardus Orlemans, PhD POZEN |
| Verification Date | January 2012 |
Locations[ + expand ][ + ]
| POZEN | Chapel Hill, North Carolina, United States, 27517 |
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