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Evaluation of the Safety and Efficacy of PENNSAID Gel in the Treatment of Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01119898
First received: April 28, 2010
Last updated: April 20, 2011
Last verified: April 2011

April 28, 2010
April 20, 2011
July 2010
February 2011   (final data collection date for primary outcome measure)
Western Ontario and McMaster Universities (WOMAC) LK3.1 Osteoarthritis (OA) Index (pain intensity) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01119898 on ClinicalTrials.gov Archive Site
  • WOMAC LK3.1 OA Index (stiffness) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • WOMAC LK3.1 OA Index (physical function) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient Global Assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pain intensity assessed on an 11-point numerical rating scale (NRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests and physical examinations [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Skin irritation [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Safety and Efficacy of PENNSAID Gel in the Treatment of Osteoarthritis of the Knee
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: PENNSAID Gel
    2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
    Other Name: diclofenac sodium 2.0% w/w
  • Drug: Vehicle
    2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
  • Experimental: PENNSAID Gel
    Diclofenac sodium 2.0% w/w
    Intervention: Drug: PENNSAID Gel
  • Placebo Comparator: Vehicle
    The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01119898
COV05100031
No
Joseph Pierro, MD, VP Medical Sciences, Mallinckrodt
Mallinckrodt
Not Provided
Study Director: Joseph Pierro, MD Mallinckrodt
Mallinckrodt
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP