Civamide in OA of the Knee(s)
An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee(s)
1 other identifier
interventional
351
1 country
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2003
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 13, 2004
CompletedFirst Posted
Study publicly available on registry
February 18, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedJune 8, 2011
February 1, 2004
1.7 years
February 13, 2004
June 6, 2011
Conditions
Interventions
Cream 0.075%, TID for 52 weeks
Eligibility Criteria
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- Subject has participated (and not withdrawn secondary to any adverse event) in the Phase 3 Osteoarthritis Study WL-1001-05-01 and completed End-of-Study/Final Visit preferably \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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Innovative Clinical Trials
Birmingham, Alabama, 35205, United States
University of Arizona
Tucson, Arizona, 85724, United States
OMC Clinical Research Center
Beverly Hills, California, 90211, United States
Med. Investigations
Fair Oaks, California, 95628, United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
Radiant Research
Daytona Beach, Florida, 32114, United States
University Clinical Research
DeLand, Florida, 32720, United States
Robert W. Levin, MD
Dunedin, Florida, 34698, United States
University Clinical Research Inc.
Pembroke Pines, Florida, 33024, United States
Radiant Research
Atlanta, Georgia, 30342, United States
Radiant Research
Boise, Idaho, 83704, United States
Feinberg School of Medicine/Office of Clinical Rsrch and Trng
Chicago, Illinois, 60611, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Chesapeake Medical Research, LLC
Baltimore, Maryland, 21239, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Medex Healthcare Research Inc.
St Louis, Missouri, 63108, United States
Arthritis Regional Research Center
Mercerville, New Jersey, 08619, United States
New Mexico Research and Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106, United States
Seligman Center for Advanced Therapeutics
New York, New York, 10003, United States
NC Arthritis and Allergy Care Center
Raleigh, North Carolina, 27609, United States
Raleigh Medical Group, PA
Raleigh, North Carolina, 27609, United States
Piedmont Medical Group
Winston-Salem, North Carolina, 27103, United States
University Hospitals of Cleveland
Beachwood, Ohio, 44122, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Radiant Research
Philadelphia, Pennsylvania, 19115, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611, United States
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090, United States
Radiant Research
Greer, South Carolina, 29651, United States
Summit Research Solutions
Memphis, Tennessee, 38119, United States
Radiant Research
Austin, Texas, 78705, United States
Arthritis and Rheumatic Diseases
Portsmouth, Virginia, 23701, United States
Physicians Pharmaceutical Study Services
Everett, Washington, 98201, United States
Arthritis Clinic
Racine, Wisconsin, 53402, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott B. Phillips, M.D.
Winston Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 13, 2004
First Posted
February 18, 2004
Study Start
November 1, 2003
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
June 8, 2011
Record last verified: 2004-02