Status:
COMPLETED
Civamide in OA of the Knee(s)
Lead Sponsor:
Winston Laboratories
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-76 years
Phase:
PHASE3
Brief Summary
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).
Detailed Description
This is a 52-week open label study wherein subjects are required to apply the study drug on the knee(s) three times a day. Subjects are required to return to the clinic every 13 weeks. Enrollment Vis...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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- Subject has participated (and not withdrawn secondary to any adverse event) in the Phase 3 Osteoarthritis Study WL-1001-05-01 and completed End-of-Study/Final Visit preferably \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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00077935
Start Date
November 1 2003
End Date
July 1 2005
Last Update
June 8 2011
Active Locations (34)
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1
Innovative Clinical Trials
Birmingham, Alabama, United States, 35205
2
University of Arizona
Tucson, Arizona, United States, 85724
3
OMC Clinical Research Center
Beverly Hills, California, United States, 90211
4
Med. Investigations
Fair Oaks, California, United States, 95628