Randomized, Double-Blind, Vehicle-Controlled, Efficacy and Safety Clinical Trial of Topically Applied OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee Following Cessation of Pain Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 3
- 主要终点
- Change in WOMAC knee pain subscale (scale 0 - 20)
研究概览
简要总结
The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
详细描述
This is a randomized, double-blind, vehicle-controlled, repeat-dose, multi-center Phase 2 efficacy and safety clinical trial of subjects with moderate to severe pain associated with osteoarthritis of the knee. Eighty-four subjects, randomized in a 2:1 ratio (OLT1177 Gel to vehicle control) will receive up to 40 doses of the Investigational Drug (56 subjects OLT1177 Gel and 28 subjects vehicle control) over 14 consecutive days given 3 times per day (4 mL per dose, TID on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1) and will have safety data collected through Day 28. Subjects with moderate to severe pain associated with osteoarthritis of the knee will be evaluated twice for eligibility: 1) at the Screening visit; and 2) at the Baseline (Day 0) visit, after a 7-day washout period of all pain medications except for trial provided Rescue Medication (500 mg/dose of acetaminophen) for those that experience unacceptable pain during the washout and 14-day treatment period.
Subjects will be encouraged not to take any pain medication during the 7-day washout period; however, for the first 5 days they are allowed to take only Rescue Medication. No pain medication, including Rescue Medication, is allowed during the 2-day pain intensity assessment period or within 48 hours of the Baseline (Day 0), Day 7 and Day 14 visits.
Subjects will be asked to record and report their level of pain at different time points throughout the 14-day trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
OLT1177 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
干预措施: OLT1177 Gel (Drug)
Placebo gel
Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)
干预措施: Placebo gel (Other)
结局指标
主要结局
Change in WOMAC knee pain subscale (scale 0 - 20)
时间窗: 14 days
The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 in WOMAC knee pain subscale (Scale 0-20), which is determined by the subjects responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4)
次要结局
- Mean group rating of Relative Knee Pain (5-point scale)(50 minutes post dose (± 10 minutes))
- Change in the use of Rescue Medication(14 days)
- Change in the time to use of Rescue Medication(14 days)
- Proportion of subjects whose POM is less than the PASS(14 days)
- Change in WOMAC knee pain subscale(7 days)
- Change in Global Rating of Disease(14 days)
- Change in Current Knee Pain (100-mm VAS)(50 minutes post dose (± 10 minutes))
- Change in Pain on Movement (100-mm VAS)(14 days)
- Proportion of subjects experiencing an improvement in WOMAC knee pain subscale(14 days)
- Proportion of subjects whose WOMAC knee pain subscale is less than the PASS(14 days)
- Proportion of subjects experiencing an improvement in Pain on Movement(14 days)
- Change in Global Evaluation of Treatment(14 days)
- Change in WOMAC Stiffness subscale (Scale 0-8)(14 days)