Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
351 participants
INTERVENTIONAL
2003-11-30
2005-07-31
Brief Summary
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Detailed Description
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Enrollment Visit (Day 1) At the End-of-Study/Final Visit, Day 84 of Study No. WL-1001-05-01 (or preferably \< 30 days following this visit) subjects will be invited to enroll in this long-term open label Study WL-1001-05-04. Subjects will sign a written informed consent prior to being enrolled into the long-term open label study. If enrolled at the final visit or \< 30 days after the final visit of Study No. WL-1001-05-01, the final visit physical examination and laboratory examination will serve as baseline for this study. If enrolled \> 30 days after the final visit, a new physical examination and laboratory examination will be completed upon enrollment into this study. The subjects will complete an OA Pain Score and Subject Global Evaluation (SGE) for their Target Knee, the same knee designated as the Target Knee in Study No. WL-1001-05-01. A 13-week supply of study drug and subject diaries for the next 13 weeks will be dispensed to each subject. Instructions on how to apply the study drug will be reviewed with the subjects. Subjects will also be instructed to complete their diaries daily (Adverse Events Log and Other Medications Log) and to return their completed diaries and study drug tubes at each clinic visit.
Treatment Period (Days 1- 365) Subjects will apply study drug to their Target Knee three times a day for 52 weeks. If the subject's other knee is affected by osteoarthritis pain, it may be treated with the study drug as well. The study drug tubes will be weighed prior to being dispensed to the subject. Each tube will also be weighed when the subject returns them.
At each clinic visit, the study staff will review the diaries with each subject for completeness and legibility.
Subjects will complete the OA Pain Score and Subject Global Evaluation at clinic visits on Day 1 and Weeks 13, 26, 39, and 52. Concurrent medications, adverse events, and study drug compliance will be reviewed and recorded by the study staff throughout the Treatment Period at clinic visits on Weeks 13, 26, 39, and 52 (End-of-Study/Final Visit). At the week 52 visit (End-of-Study/Final Visit), a physical examination and laboratory examination will be performed.
On Day 365 (End-of-Study/Final Visit) the subject will be discharged after all procedures have been completed.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Civamide
Cream 0.075%, TID for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
76 Years
ALL
Yes
Sponsors
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Winston Laboratories
INDUSTRY
Responsible Party
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Winston Laboratories, Inc.
Principal Investigators
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Scott B. Phillips, M.D.
Role: STUDY_DIRECTOR
Winston Laboratories
Locations
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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
Radiant Research
Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, United States
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, United States
Radiant Research
Greer, South Carolina, United States
Summit Research Solutions
Memphis, Tennessee, United States
Radiant Research
Austin, Texas, United States
Arthritis and Rheumatic Diseases
Portsmouth, Virginia, United States
Physicians Pharmaceutical Study Services
Everett, Washington, United States
Arthritis Clinic
Racine, Wisconsin, United States
Countries
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Other Identifiers
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WL-1001-05-04
Identifier Type: -
Identifier Source: org_study_id
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