Civamide in OA of the Knee(s)

Completed · Phase 3

Conditions studied: Osteoarthritis, Knee

In brief

The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s).

Key facts

Study ID

NCT00077935

Run by

Winston Laboratories

People needed

351

Starts

2003-11-01

Expected to finish

2005-07-01

Last updated by the study team

2011-06-08

Who can join

Age: 40 and older, up to 76. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent.
• Subject has participated (and not withdrawn secondary to any adverse event) in the Phase 3 Osteoarthritis Study WL-1001-05-01 and completed End-of-Study/Final Visit preferably < 30 days prior to Day 1 of this study (WL-1001-05-04).
• Subject is between 40 and 76 years of age.
• Subject is generally in good health.
• Subject is expected to be compliant with study procedures.
• Female subjects of child-bearing potential must have a negative urine pregnancy test at Day 1.
• Female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study.

You may not qualify if…

• Presence of tendonitis, bursitis, partial or complete joint replacement of knee(s).
• Presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s).
• Subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study.
• Subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.
• Subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening.
• Subject has Type I or Type II diabetes with peripheral neuropathies.
• Subject has had trauma or surgery to the knee(s) within 1 year prior to the Enrollment Period.
• Subject has an underlying clinical condition, including previous malignancies that in the Investigator's judgment, is unstable.
• Subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.
• Subject has a history of substance abuse within the past 12 months.
• Use of certain medications within the given restriction period prior to randomization and during the study.

Where it is running

• Innovative Clinical Trials — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• OMC Clinical Research Center — Beverly Hills, California, United States
• Med. Investigations — Fair Oaks, California, United States
• Boling Clinical Trials — Rancho Cucamonga, California, United States
• Radiant Research — Daytona Beach, Florida, United States
• University Clinical Research — DeLand, Florida, United States
• Robert W. Levin, MD — Dunedin, Florida, United States
• University Clinical Research Inc. — Pembroke Pines, Florida, United States
• Radiant Research — Atlanta, Georgia, United States
• Radiant Research — Boise, Idaho, United States
• Feinberg School of Medicine/Office of Clinical Rsrch and Trng — Chicago, Illinois, United States
• Physicians Research Group — Indianapolis, Indiana, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Chesapeake Medical Research, LLC — Baltimore, Maryland, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Medex Healthcare Research Inc. — St Louis, Missouri, United States
• Arthritis Regional Research Center — Mercerville, New Jersey, United States
• New Mexico Research and Osteoporosis Center, Inc. — Albuquerque, New Mexico, United States
• Seligman Center for Advanced Therapeutics — New York, New York, United States
• NC Arthritis and Allergy Care Center — Raleigh, North Carolina, United States
• Raleigh Medical Group, PA — Raleigh, North Carolina, United States
• Piedmont Medical Group — Winston-Salem, North Carolina, United States
• University Hospitals of Cleveland — Beachwood, Ohio, United States
• Hightop Medical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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