Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee

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