Civamide in OA of the Knee(s)

Osteoarthritis, Knee Clinical Trial

Official title:

An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee(s)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077935
• Other study ID #: WL-1001-05-04
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2004
• Last updated: June 6, 2011
• Start date: November 2003
• Est. completion date: July 2005

Study information

• Verified date: February 2004
• Source: Winston Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 76 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Civamide
Cream 0.075%, TID for 52 weeks

Locations

Country	Name	City	State
United States	New Mexico Research and Osteoporosis Center, Inc.	Albuquerque	New Mexico
United States	Radiant Research	Atlanta	Georgia
United States	Radiant Research	Austin	Texas
United States	Chesapeake Medical Research, LLC	Baltimore	Maryland
United States	University Hospitals of Cleveland	Beachwood	Ohio
United States	OMC Clinical Research Center	Beverly Hills	California
United States	Innovative Clinical Trials	Birmingham	Alabama
United States	Radiant Research	Boise	Idaho
United States	Feinberg School of Medicine/Office of Clinical Rsrch and Trng	Chicago	Illinois
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	Radiant Research	Daytona Beach	Florida
United States	University Clinical Research	DeLand	Florida
United States	Robert W. Levin, MD	Dunedin	Florida
United States	Physicians Pharmaceutical Study Services	Everett	Washington
United States	Med. Investigations	Fair Oaks	California
United States	Radiant Research	Greer	South Carolina
United States	Physicians Research Group	Indianapolis	Indiana
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Summit Research Solutions	Memphis	Tennessee
United States	Arthritis Regional Research Center	Mercerville	New Jersey
United States	Seligman Center for Advanced Therapeutics	New York	New York
United States	University Clinical Research Inc.	Pembroke Pines	Florida
United States	Radiant Research	Philadelphia	Pennsylvania
United States	Arthritis and Rheumatic Diseases	Portsmouth	Virginia
United States	Arthritis Clinic	Racine	Wisconsin
United States	NC Arthritis and Allergy Care Center	Raleigh	North Carolina
United States	Raleigh Medical Group, PA	Raleigh	North Carolina
United States	Boling Clinical Trials	Rancho Cucamonga	California
United States	Medex Healthcare Research Inc.	St. Louis	Missouri
United States	University of Arizona	Tucson	Arizona
United States	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania
United States	Heartland Research Associates	Wichita	Kansas
United States	Rheumatic Disease Associates, Ltd.	Willow Grove	Pennsylvania
United States	Piedmont Medical Group	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Winston Laboratories

Country where clinical trial is conducted

United States,