Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Propella Therapeutics; Vizuri Health Sciences LLC
• Collaborators: Palm Beach CRO; Palm Beach Research, Inc
• Treatments: Capsaicin

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).