A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
Condition: Osteoarthritis, Knee; Pain
MeSH terms: Osteoarthritis, Knee
Intervention: CGS-200-1; CGS-200-5; CGS-200 Vehicle
Intervention description: CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.; CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.; CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Intervention MeSH terms: Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-blind clinical trial to examine the comparative
      effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content)
      (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according
      to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied
      at the clinic for 60 minutes on each of four consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis (OA) of both knees;

          -  OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within
             the past 6 months;

          -  Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) <40 mm/hr;

          -  Chronic knee pain in at least 1 knee for > 3 months;

          -  WOMAC pain score of > 250 (using VAS WOMAC format) at screening, and at baseline, in
             at least one knee;

          -  Knee pain score of > 5 on the NRS pain scale at screening, and at baseline, in at
             least one knee;

          -  Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic
             knee injury in medical history);

          -  No burning-stinging pain, unrelated to subject's knee pain, at intended site of
             application;

          -  Knee pain must be greater than pain in any other part of subject's body;

          -  American College of Rheumatology (ACR) global functional status I, II, or III
             (excluding IV).

        Exclusion Criteria:

          -  Spontaneously improving or rapidly deteriorating OA of the knee;

          -  Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout),
             Paget's disease of bone, or any other disease affecting the joints that are
             inconsistent with a diagnosis of idiopathic OA;

          -  Labile or poorly controlled hypertension;

          -  Use of steroids for 1 month prior to screening, or
             intraarticular-visco-supplementation within 3 months prior to screening;

          -  Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks
             prior to screening;

          -  Used topically applied products (including emollients or moisturizers) on or in the
             vicinity of the knees or shaved the knees within 2 days prior to the first application
             of study drug; or an open wound near the knee; cutaneous erythema or edema; any
             inflammatory skin lesions such as eczema or psoriasis; cutaneous infections; or any
             other compromise of the skin;

          -  Requires or anticipates any surgical procedure within 3 months prior to screening, has
             had surgery on the affected joint within 6 months prior to screening, has a prosthesis
             in either knee, or would require surgery while participating in the trial.