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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119898
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : April 21, 2011
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: PENNSAID Gel Drug: Vehicle Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: PENNSAID Gel
Diclofenac sodium 2.0% w/w
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

Placebo Comparator: Vehicle
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Drug: Vehicle
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks

Primary Outcome Measures :
  1. Western Ontario and McMaster Universities (WOMAC) LK3.1 Osteoarthritis (OA) Index (pain intensity) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. WOMAC LK3.1 OA Index (stiffness) [ Time Frame: 4 weeks ]
  2. WOMAC LK3.1 OA Index (physical function) [ Time Frame: 4 weeks ]
  3. Patient Global Assessment [ Time Frame: 4 weeks ]
  4. Pain intensity assessed on an 11-point numerical rating scale (NRS) [ Time Frame: 4 weeks ]
  5. Use of rescue medication [ Time Frame: 4 weeks ]
  6. Clinical laboratory tests and physical examinations [ Time Frame: 4 weeks ]
  7. Adverse events [ Time Frame: 4 weeks ]
  8. Skin irritation [ Time Frame: 4 weeks ]
  9. Vital signs [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01119898

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Sponsors and Collaborators
Study Director: Joseph Pierro, MD Mallinckrodt

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joseph Pierro, MD, VP Medical Sciences, Mallinckrodt Identifier: NCT01119898     History of Changes
Other Study ID Numbers: COV05100031
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: April 21, 2011
Last Verified: April 2011

Keywords provided by Mallinckrodt:
Topical NSAID

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action