Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Capsaicin Topical Solution; Drug product vehicle
Intervention description: Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin; This is the vehicle for the active treatment drug product, but without capsaicin
Intervention MeSH terms: Capsaicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active treatment compared to drug vehicle as placebo
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study medications were number coded only and identical in physical characteristics. Randomization coding was held only at the manufacturing site until data base lock.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: knee pain, capsaicin, topical, osteoarthritis

Summary:

      This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for
      management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs)
      Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For
      Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final
      proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion
      criteria were randomized into one of four groups: once daily treatment with active product,
      once daily treatment with product vehicle (no capsaicin), twice daily treatment with active
      product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive
      days of treatment. The twice daily treatments were spaced approximately 12 hours apart.
      Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee
      pain assessments were done each day for 28 days. Tolerability data were also collected.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has granted written informed consent.

          2. Subject is at least 18 years of age.

          3. Subject has knee pain with radiographic evidence of osteoarthritis in at least one
             knee (including an x-ray within the previous 2 years).

          4. Subject's osteoarthritis knee pain has been present for ≥ 6 months.

          5. Subject has osteoarthritis knee pain of ≥ 50 mm in one knee based on the visual analog
             scale at screening.

          6. Subject has regularly used topical over-the-counter pain relief products or
             over-the-counter oral medication (acetaminophen or ibuprofen) to treat/manage pain
             from osteoarthritis in the previous 3 months.

          7. Subject is in good general health and free of any disease state or physical condition
             which, in the investigator's opinion, exposes the subject to an unacceptable risk by
             study participation.

          8. Subject is capable of understanding and complying with all instructions and study
             procedures, including the ability to accurately evaluate their symptoms.

          9. Subject must be a male or non-pregnant female. If female, subject must be past
             childbearing age or otherwise must test negative for pregnancy. Males and females must
             agree to use effective birth control during the study or for at least 30 days after
             last dose of study investigational product, if unable to complete the study.

        Exclusion Criteria:

          1. Subject has spontaneously improving or rapidly deteriorating osteoarthritis or knee
             pain.

          2. Subject has rheumatoid or psoriatic arthritis, or a form of arthritis inconsistent
             with a diagnosis of osteoarthritis.

          3. Subject has used any topical steroids on or in the vicinity of the knees within 1 week
             prior to Screening, or has had a knee injection within 1 month prior to Screening.

          4. Subject is currently taking prescription pain medication.

          5. Subject has shaved their knees within 2 days of first day of treatment (Day 1).

          6. Subject has used any capsaicin containing product on or in the vicinity of the knees
             within 2 weeks prior to first day of treatment (Day 1).

          7. Subject has used any topically applied products (including emollient/moisturizer) on
             or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day
             1).

          8. Subject has used topical therapy on the knees that, in the investigator's opinion,
             might affect the study evaluations of signs and/or symptoms.

          9. Subject has broken or damaged skin on their knees, or an open wound near the knees.

         10. Subject has a history of allergy/sensitivity to topical substances.

         11. Subject is not able to understand the nature, importance, or consequences of the
             study.

         12. Subject has a psychiatric disorder or has significant anxiety or depression that, in
             the investigator's opinion, could interfere with the subject's ability to accurately
             assess their pain, adhere to study instructions, or complete the study.

         13. Subject has hypertension that is not adequately controlled (medication to treat
             hypertension is allowed), vascular disease, psychological disorder, or other condition
             that, in the investigator's opinion, contraindicate the use of medication.

         14. Is obese with a Body Mass Index (BMI) of greater than 40 kg/m2.

         15. Subject requires a surgical procedure in the immediate future.

         16. Subject is pregnant or nursing.

         17. Subject has been treated with an investigational drug, device, or therapy within 30
             days prior to first day of treatment (Day 1).