Clinical trial: Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee (NCT01768975)

Eligibility criteria:
Inclusion Criteria:

          -  Age 35 to 80

          -  Subjects of childbearing potential and their partners must use effective contraception

          -  OA based on the ACR criteria

          -  OA of the knee ≥ 6 months prior to Screening

          -  OA knee pain which required NSAID or other therapy for ≥ 15 days

          -  Pain on Movement in the contralateral knee be ≤ 20 mm

          -  Radiographic evidence of OA by Kellgren-Lawrence score of 2 or 3 taken 6 months prior
             to Screening

          -  Moderate to severe OA pain defined as POM score between 50 mm and 90 mm

          -  Baseline WOMAC pain subscale score ≥ 9

          -  No change in physical activity and/or therapy for the past 3 months

          -  Provide written informed consent and comply with the trial

        Exclusion Criteria:

          -  Use of Rescue Medication or any other pain medication 48 hours prior to Baseline visit

          -  Inflammatory skin condition over the target knee

          -  Extreme pain in the target knee characterized by POM score of > 90 mm

          -  Mild pain in the target knee, characterized by POM score of < 50 mm

          -  > 30 mm POM score variability in Days -2 to -1 from Baseline visit

          -  Baseline POM score of > 20 mm for the contralateral knee or any other significant
             joint or general pain at Baseline visit

          -  Excessive effusion in the target knee

          -  Heat and/or redness in comparison to the contralateral knee

          -  Knock-kneed or bow-legged defined by valgus or varus deformity of ≥ 15 degrees

          -  Acute or chronic injury other than OA

          -  Radiographic evidence of OA by Kellgren-Lawrence score of 0, 1 or 4

          -  Open surgery of the target knee within the last year

          -  Arthroscopic surgery of the target knee within the last 6 months

          -  Surgery of the target knee requiring insertion of a medical device or surgical
             hardware

          -  Use of prohibited concomitant medications/therapies during the 7-day washout period or
             planned use during the 14-day treatment period including:

               1. Prescription medications to treat pain, OTC and natural supplements

               2. Muscle relaxants unless on a stable dose ≥ 30 days prior to Screening

               3. Nutraceuticals unless on a stable dose ≥ 3 months prior to Screening

               4. Sedative hypnotics unless on a stable dose ≥ 30 days prior to Screening

               5. Devices or therapeutic treatments for knee pain or ambulation

               6. Systemic corticosteroids

               7. Other Investigational Drugs

               8. Chemotherapeutic drugs

               9. Immunotherapy

              10. Topical products applied to the target knee

              11. Cyclosporine (except ophthalmic), lithium, methotrexate

              12. Anti-depressants or medications acting on the central nervous system, unless on a
                  stable dose for depression ≥ 3 months prior to Screening

              13. Narcotics or previous history of chronic narcotic use

              14. Rescue Medication within 48 hours of Baseline, Day 7 or Day 14 visits

          -  Intraarticular steroids in the target knee within the previous 3 months or in any
             other joint within the previous 30 days

          -  Intraarticular hyaluronate within the previous 6 months or in any other joint within
             the previous 30 days

          -  Systemic corticosteroids within the prior month

          -  Documented history of inflammatory joint disease

          -  BMI over 35

          -  Uncontrolled psychiatric conditions

          -  Cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or
             neurological disease or prior surgery

          -  Uncontrolled hypertension

          -  Diabetes with an HbA1c level > 8

          -  Known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis
             C Virus (HCV)

          -  Cancer within the past 5 years, except for treated basal cell or squamous cell
             carcinoma of the skin

          -  Any other medical conditions, diseases or prior surgeries

          -  Interventional and/or surgical procedure during the 28 days following randomization

          -  Change in level of physical activity during the 28 days following randomization

          -  Active infection or fever ≥ 38°C within 3 days of Baseline visit

          -  Known sensitivity to Investigational Drug

          -  Women planning to become pregnant during the 28-day trial

          -  Participation in any Investigational Drug or device trial within 30-day prior to
             Baseline visit
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 80 Years

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