Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
NCT ID: NCT00665431
Last Updated: 2011-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
610 participants
INTERVENTIONAL
2008-04-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 PN 400 (VIMOVO)
PN400: 500 mg naproxen/20 mg esomeprazole bid
PN 400 (VIMOVO)
500 mg naproxen/20 mg esomeprazole bid
Rescue Antacid
Antacid Tablets
Arm 2 (Celebrex)
Celecoxib 200 mg
celebrex
200 mg celecoxib qd
Rescue Antacid
Antacid Tablets
Arm 3 (Placebo)
sugar pill
Placebo
sugar pill bid
Rescue Antacid
Antacid Tablets
Interventions
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PN 400 (VIMOVO)
500 mg naproxen/20 mg esomeprazole bid
celebrex
200 mg celecoxib qd
Placebo
sugar pill bid
Rescue Antacid
Antacid Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 Current oral analgesic therapy was withdrawn at Screening.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
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
50 Years
ALL
No
Sponsors
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POZEN
INDUSTRY
Responsible Party
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Pozen
Principal Investigators
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Everardus Orlemans, PhD
Role: STUDY_CHAIR
POZEN
Locations
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POZEN
Chapel Hill, North Carolina, United States
Countries
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References
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Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Jul;43(3):200-12. doi: 10.1080/00913847.2015.1074852. Epub 2015 Aug 3.
Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Aug 3:1-13. Online ahead of print.
Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011 Jun;27(6):1243-53. doi: 10.1185/03007995.2011.580340. Epub 2011 Apr 28.
Other Identifiers
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PN400-309
Identifier Type: -
Identifier Source: org_study_id