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
  Purpose

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 Intervention Phase
Osteoarthritis of the Knee
Drug: PENNSAID Gel
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities (WOMAC) LK3.1 Osteoarthritis (OA) Index (pain intensity) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 260
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PENNSAID Gel
Diclofenac sodium 2.0% w/w
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
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119898

  Hide Study Locations
Locations
United States, Arizona
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, California
Benchmark Research
Sacramento, California, United States, 95816
United States, Florida
Tampa Bay Medical Research, Inc
Clearwater, Florida, United States, 33761
Avail Clinical Research
DeLand, Florida, United States, 32724
Comprehensive NeuroScience Inc.
St. Petersburg, Florida, United States, 33716
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
South Coast Medical Group
Savannah, Georgia, United States, 31406
United States, Kansas
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States, 66206
United States, Kentucky
Sterling Research
Erlanger, Kentucky, United States, 41018
United States, Missouri
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
Radiant Research Inc.
St. Louis, Missouri, United States, 63141
United States, North Carolina
Clinical Study Center of Asheville
Asheville, North Carolina, United States, 28803
Peters Medical Research, LLC
High Point, North Carolina, United States, 27262
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
New Hanover Medical Research
Wilmington, North Carolina, United States, 28401
United States, Ohio
Sterling Research
Cincinnati, Ohio, United States, 45246
Radiant Research Inc.
Columbus, Ohio, United States, 43212
Clinical Research Source, Inc.
Perrysburg, Ohio, United States, 43551
United States, South Carolina
Radiant Research Inc.
Anderson, South Carolina, United States, 29261
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States, 37660
United States, Texas
Benchmark Research
Ft. Worth, Texas, United States, 76135
Benchmark Research
San Angelo, Texas, United States, 76904
Sun Research Institute
San Antonio, Texas, United States, 78215
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
HypotheTest, LLC
Roanoke, Virginia, United States, 24018
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Joseph Pierro, MD Mallinckrodt
  More Information

No publications provided

Responsible Party: Joseph Pierro, MD, VP Medical Sciences, Mallinckrodt
ClinicalTrials.gov Identifier: NCT01119898     History of Changes
Other Study ID Numbers: COV05100031
Study First Received: April 28, 2010
Last Updated: April 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Osteoarthritis
Arthritis
NSAIDs
Topical NSAID
Diclofenac
PENNSAID

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

ClinicalTrials.gov processed this record on October 02, 2014