Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
- Registration Number
- NCT01119898
- Lead Sponsor
- Mallinckrodt
- Brief Summary
Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life.
OA can occur in any joint, but usually affects the hands, knees, hips or spine.
The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Primary osteoarthritis of the knee
- Radiologic evidence of OA of the knee
- On stable pain therapy with an oral or topical NSAID or acetaminophen
- Experience a "moderate flare" of pain following washout of stable pain therapy
- Able to read and understand English or Spanish to answer pain assessment questions without any explanation
- If female, surgically sterile or non-pregnant
- Except for OA, in reasonably good general health
- Written informed consent
- Secondary OA of the study knee
- History of pseudo gout or inflammatory flare-ups
- Participation would conflict with contraindications, warnings or precautions as stated in the prescribing information for oral or topical diclofenac
- Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease
- Any malignancy within the previous 3 years, except local therapy for superficial skin cancer not on the study knee
- Known sensitivity to the use of oral or topical diclofenac, aspirin [acetylsalicylic acid (ASA)] or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol
- Ongoing abnormality that could confound interpretation of the safety results (eg, anemia, unresponsive gastrointestinal [GI] reflux, etc.)
- Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the last 6 months
- Uncontrolled diabetes
- 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
- Documented alcohol or drug abuse within 1 year
- If female, breast-feeding
- Major surgery or previous damage to the study knee at any time, or minor knee surgery to the study knee within 1 year
- 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
- Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the study knee in the past 6 months
- 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.
- Recently started taking a sedative hypnotic medication for insomnia
- Taking anti-depressants
- Not willing to discontinue prohibited medications/therapies
- Cannot tolerate acetaminophen
- Re-entering study after dropping out or withdrawn from study
- Used another investigational drug within the previous 30 days
- On or currently applying for disability benefits on the basis of knee OA
- History of fibromyalgia
- Other painful or disabling conditions affecting the knee or leg, or disabling condition of the hands (used to apply the study drug)
- Skin disorder with current involvement on the hands (used to apply the study drug) or the knee(s) (application site)
- Referred to an orthopedic surgeon for consideration of, or been advised to have, knee replacement or knee reconstruction surgery
- Radiologic evidence of OA of the knee advanced to the point that all cartilage has been eroded (ie, bone on bone)
- Recently started using a cane within the past 30 days
- History of chronic headaches that may require more than occasional use of rescue medication for headaches
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PENNSAID Gel PENNSAID Gel Diclofenac sodium 2.0% w/w Vehicle Vehicle The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
- Primary Outcome Measures
Name Time Method Pain At Night While In Bed at Week 4 Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain While Standing at Week 4 Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain When Going Up Or Down Stairs at Week 4 Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain While Sitting Or Lying Down at Week 4 Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain When Walking On A Flat Surface at Week 4 Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Clinical Trials Technology, Inc.
🇺🇸Prairie Village, Kansas, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Palmetto Medical Research
🇺🇸Mount Pleasant, South Carolina, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Avail Clinical Research
🇺🇸DeLand, Florida, United States
Clinical Research Source, Inc.
🇺🇸Perrysburg, Ohio, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
New Hanover Medical Research
🇺🇸Wilmington, North Carolina, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Comprehensive NeuroScience Inc.
🇺🇸Saint Petersburg, Florida, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
Tampa Bay Medical Research, Inc
🇺🇸Clearwater, Florida, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
South Coast Medical Group
🇺🇸Savannah, Georgia, United States
Radiant Research Inc.
🇺🇸Anderson, South Carolina, United States
Holston Medical Group Clinical Research
🇺🇸Kingsport, Tennessee, United States
Clinical Study Center of Asheville
🇺🇸Asheville, North Carolina, United States
Sterling Research
🇺🇸Cincinnati, Ohio, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
HypotheTest, LLC
🇺🇸Roanoke, Virginia, United States