Clinical trial: Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200 (NCT03124407)

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).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment