Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)

This study has been completed.
Sponsor:
Information provided by:
Winston Laboratories
ClinicalTrials.gov Identifier:
NCT00995306
First received: February 25, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and symptoms associated with osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Civamide (Zucapsaicin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Controlled, Parallel-Group, Multicenter Study Evaluating the Safety and Efficacy of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Winston Laboratories:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain
  • WOMAC Physical Function
  • Subject's Global Evaluation

Enrollment: 695
Study Start Date: June 2003
Study Completion Date: June 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Civamide Cream 0.075%
Drug: Civamide (Zucapsaicin)

Civamide Cream 0.075%, TID for 12 weeks

Civamide Cream 0.01%, TID for 12 weeks

Other Names:
  • Civamide
  • Zucapsaicin
Active Comparator: 2
Civamide Cream 0.01%
Drug: Civamide (Zucapsaicin)

Civamide Cream 0.075%, TID for 12 weeks

Civamide Cream 0.01%, TID for 12 weeks

Other Names:
  • Civamide
  • Zucapsaicin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to entry into the Screening Period (Day -3).
  2. Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of > 9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 = none; 4 = extreme.
  3. Subject must have a Functional Capacity Classification of I-III.
  4. Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at least 22 of the previous 28 days and for each of the 2 days prior to the Screening Period (Day -3) and for at least each of the 2 days prior to the Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to remain on this stable daily dose throughout the study.
  5. Subject is between 40-75 years of age.
  6. Diagnosis of OA is present for at least 6 months according to the ACR criteria for OA of the knee.
  7. Radiographic evidence of OA of the Target Knee (within the last 3 years) with a Kellgren-Lawrence scale of 2 or 3.
  8. Subject is generally in good health.
  9. Subject is expected to be compliant with study procedures.
  10. Females of child-bearing potential must have a negative urine pregnancy test at Screening.
  11. 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:

  1. Presence of tendonitis, bursitis, partial or complete joint replacement of Target Knee.
  2. Presence of active skin disease, erythema, infection, wound or irritation near the treatment area of the Target Knee.
  3. Subject has history of frequent headache or other painful conditions (other than OA) that is expected to require any use of systemic opiates or derivatives, or more than twice a week additional administration of different oral NSAIDs or COX-2 inhibitors (see Section 6.1, Table 2).
  4. Subject experiences regular significant pain due to osteoarthritis or other conditions in the non-target knee or other joints while on stable doses of their current analgesic therapy.
  5. Subject has an anticipated need for any surgical or other invasive procedure that will be performed on the Target Knee or other part of the body during the course of the study.
  6. OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium crystal deposition disease, neuropathic arthropathy, frostbite, congenital abnormalities.
  7. Subject has 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.
  8. Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months prior to screening.
  9. Subject has Type I or Type II diabetes with peripheral neuropathies.
  10. Subject is extremely obese with BMI ≥ 39.
  11. Subject has had trauma to or surgery on the Target Knee within 1 year of Screening/Baseline.
  12. Subject has an underlying clinical condition, including previous malignancies that in the Investigator's judgment, is unstable.
  13. Subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.
  14. Subject has a history of substance abuse within the past 12 months.
  15. Subject has participated in previous clinical study with Civamide Cream.
  16. Use of restricted medications (See Medication/Treatment Table, Section 5.1.2).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995306

Sponsors and Collaborators
Winston Laboratories
Investigators
Study Director: Scott B Phillips, M.D. Winston Laboratories
  More Information

No publications provided

Responsible Party: Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00995306     History of Changes
Other Study ID Numbers: WL-1001-05-01, OA of the knee
Study First Received: February 25, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Winston Laboratories:
Active comparator
Active civamide cream, 0.075%
Active civamide cream, 0.01%

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014