Evaluation of the Safety and Efficacy of PENNSAID Gel in the Treatment of Osteoarthritis of the Knee
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 40 - 85 |
Updated: | 12/6/2017 |
Start Date: | July 2010 |
End Date: | March 2011 |
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Clinical Study to Evaluate the Safety and Efficacy of PENNSAID Gel in the Symptomatic Treatment of Osteoarthritis of the Knee
Osteoarthritis (OA) is the most common form of arthritis and can cause pain, swelling, and
reduced motion in the joints, which as a result can impact quality of life. It can occur in
any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is
to determine the efficacy and safety of a topical nonsteroidal anti-inflammatory drug (NSAID)
gel formulation in the treatment of osteoarthritis of the knee.
reduced motion in the joints, which as a result can impact quality of life. It can occur in
any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is
to determine the efficacy and safety of a topical nonsteroidal anti-inflammatory drug (NSAID)
gel formulation in the treatment of osteoarthritis of the knee.
Subjects with OA of the knee who complete a washout of all pain medication will be randomized
to either a topical NSAID gel formulation (active study drug) or placebo. Study drug or
placebo will be applied twice a day to the osteoarthritic knee during a 4-week treatment
period. Subjects will receive acetaminophen for rescue medication as needed to treat pain
during the treatment period. Subjects will report pain intensity, drug application
information and use of rescue medication every day and complete the WOMAC LK3.1 OA Index and
a Patient Global Assessment at clinic visits. Safety assessments include adverse events, skin
irritation assessments, clinical laboratory tests, physical examinations and vital signs.
to either a topical NSAID gel formulation (active study drug) or placebo. Study drug or
placebo will be applied twice a day to the osteoarthritic knee during a 4-week treatment
period. Subjects will receive acetaminophen for rescue medication as needed to treat pain
during the treatment period. Subjects will report pain intensity, drug application
information and use of rescue medication every day and complete the WOMAC LK3.1 OA Index and
a Patient Global Assessment at clinic visits. Safety assessments include adverse events, skin
irritation assessments, clinical laboratory tests, physical examinations and vital signs.
Inclusion Criteria:
1. Primary osteoarthritis of the knee
2. Radiologic evidence of OA of the knee
3. On stable pain therapy with an oral or topical NSAID or acetaminophen
4. Experience a "moderate flare" of pain following washout of stable pain therapy
5. Able to read and understand English or Spanish to answer pain assessment questions
without any explanation
6. If female, surgically sterile or non-pregnant
7. Except for OA, in reasonably good general health
8. Written informed consent
Exclusion Criteria:
1. Secondary OA of the study knee
2. History of pseudo gout or inflammatory flare-ups
3. Participation would conflict with contraindications, warnings or precautions as stated
in the prescribing information for oral or topical diclofenac
4. Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease
5. Any malignancy within the previous 3 years, except local therapy for superficial skin
cancer not on the study knee
6. Known sensitivity to the use of oral or topical diclofenac, aspirin (acetylsalicylic
acid [ASA]) or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol
7. Ongoing abnormality that could confound interpretation of the safety results (eg,
anemia, unresponsive gastrointestinal [GI] reflux, etc.)
8. Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the
last 6 months
9. Uncontrolled diabetes
10. Screening laboratory test results of serum creatinine ≥ 1.5 times upper limit of
normal; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
gamma-glutamyltransferase (GGT) ≥ 3 times upper limit of normal; and hemoglobin less
than or equal to lower limit of normal
11. Documented alcohol or drug abuse within 1 year
12. If female, breast-feeding
13. Major surgery or previous damage to the study knee at any time, or minor knee surgery
to the study knee within 1 year
14. Requires oral or intra-muscular corticosteroids, or received an intra articular
corticosteroid injection into the study knee within the past 90 days, or into any
other joint within the past 30 days, or currently applying topical corticosteroids
onto the study knee
15. Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the
study knee in the past 6 months
16. On prior stable therapy (ie, more than 3 days per week for the previous month) with an
opioid analgesic prior to the screening visit will be excluded.
17. Recently started taking a sedative hypnotic medication for insomnia
18. Taking anti-depressants
19. Not willing to discontinue prohibited medications/therapies
20. Cannot tolerate acetaminophen
21. Re-entering study after dropping out or withdrawn from study
22. Used another investigational drug within the previous 30 days
23. On or currently applying for disability benefits on the basis of knee OA
24. History of fibromyalgia
25. Other painful or disabling conditions affecting the knee or leg, or disabling
condition of the hands (used to apply the study drug)
26. Skin disorder with current involvement on the hands (used to apply the study drug) or
the knee(s) (application site)
27. Referred to an orthopedic surgeon for consideration of, or been advised to have, knee
replacement or knee reconstruction surgery
28. Radiologic evidence of OA of the knee advanced to the point that all cartilage has
been eroded (ie, bone on bone)
29. Recently started using a cane within the past 30 days
30. History of chronic headaches that may require more than occasional use of rescue
medication for headaches
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