Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee
Osteoarthritis of the Knee
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Knee, Osteoarthritis, OA, Knee pain, Moderate pain, Severe pain, Inflammation, Safety, Efficacy, Randomized, Topical, Gel, Olatec, OLT1177, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Therapeutic, Analgesic
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:
- Prescription medications to treat pain, OTC and natural supplements
- Muscle relaxants unless on a stable dose ≥ 30 days prior to Screening
- Nutraceuticals unless on a stable dose ≥ 3 months prior to Screening
- Sedative hypnotics unless on a stable dose ≥ 30 days prior to Screening
- Devices or therapeutic treatments for knee pain or ambulation
- Systemic corticosteroids
- Other Investigational Drugs
- Chemotherapeutic drugs
- Immunotherapy
- Topical products applied to the target knee
- Cyclosporine (except ophthalmic), lithium, methotrexate
- Anti-depressants or medications acting on the central nervous system, unless on a stable dose for depression ≥ 3 months prior to Screening
- Narcotics or previous history of chronic narcotic use
- 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
Sites / Locations
- Avail Clinical Research
- Miami Research Associates
- Wake Research Associates
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
OLT1177 Gel
Placebo gel
4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1
Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)