Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

Completed · Phase 2

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT01119898

Run by

Mallinckrodt

People needed

260

Starts

2010-08-02

Expected to finish

2011-02-16

Last updated by the study team

2019-10-22

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Genova Clinical Research — Tucson, Arizona, United States
• Benchmark Research — Sacramento, California, United States
• Tampa Bay Medical Research, Inc — Clearwater, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• Comprehensive NeuroScience Inc. — St. Petersburg, Florida, United States
• Drug Studies America — Marietta, Georgia, United States
• South Coast Medical Group — Savannah, Georgia, United States
• Clinical Trials Technology, Inc. — Prairie Village, Kansas, United States
• Sterling Research — Erlanger, Kentucky, United States
• Radiant Research Inc. — St Louis, Missouri, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• Clinical Study Center of Asheville — Asheville, North Carolina, United States
• Peters Medical Research, LLC — High Point, North Carolina, United States
• Crescent Medical Research — Salisbury, North Carolina, United States
• New Hanover Medical Research — Wilmington, North Carolina, United States
• Sterling Research — Cincinnati, Ohio, United States
• Radiant Research Inc. — Columbus, Ohio, United States
• Clinical Research Source, Inc. — Perrysburg, Ohio, United States
• Radiant Research Inc. — Anderson, South Carolina, United States
• Palmetto Medical Research — Mt. Pleasant, South Carolina, United States
• Holston Medical Group Clinical Research — Kingsport, Tennessee, United States
• Benchmark Research — Fort Worth, Texas, United States
• Benchmark Research — San Angelo, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States
• Charlottesville Medical Research — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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