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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00995306
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : June 10, 2011
Information provided by:
Winston Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Civamide (Zucapsaicin) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 695 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2003
Actual Primary Completion Date : April 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00995306

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

Responsible Party: Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc. Identifier: NCT00995306     History of Changes
Other Study ID Numbers: WL-1001-05-01
OA of the knee
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

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

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs