A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Dose Ranging Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Time averaged change from baseline in a standard 100 mm Visual Analog Scale (VAS).
研究概览
简要总结
A double-blind, placebo-controlled, randomized dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for treatment of chronic pain associated with osteoarthritis of the knee compared to inactive placebo.
详细描述
The study is a double-blind, placebo-controlled, dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for the treatment of chronic pain associated with osteoarthritis of the knee compared to the inactive vehicle as a placebo.
A maximum of 120 subjects will be enrolled. Subjects will self-treat for 7 (+2) days, applied in the morning and at bed time.
The active pharmaceutical ingredient is copper. The proposed doses in the study are less than 2% of the upper limit of the RDA (0.9 mg/day, upper limit 10mg/day).
Rescue medication is acetaminophen, up to ~2g daily (Up to six Tylenol Regular Strength tablets).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participant, Investigator
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee according to American College of Rheumatology clinical radiological criteria. A knee radiograph will be ordered and reviewed.
- •OA of the knee >/= 6 months prior to screening. Subjects with OA of both knees will treat the worst knee.
- •Age 40 years or older
- •Males or females of non-childbearing potential (12 or more months of spontaneous amenorrhea, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or for females over 50 years of age, hysterectomy without bilateral oophorectomy at least 6 months prior to randomization.; female subjects of childbearing potential must agree to use contraception (abstinence, birth control pills, rings or patches, diaphragm an spermicide, intrauterine device, condom and vaginal spermicide, surgical sterilization, vasectomy, progestin implant or injection); female partners of childbearing potential of male subjects must agree to use contraception as defined above.
- •Moderate to severe OA pain defined a POM score between 40 mm and 90 mm.
- •Baseline WOMAC pain subscale score >/=
- •No change in physical activity and/or therapy for the past 3 months.
- •All concurrent medications taken for any reason stable for 14 days
- •Ability to follow protocol with reference to cognitive and situational factors such as stable housing, ability to attend visits.
- •Ability to read and write English.
- •Ability to apply cream without assistance.
- •Able to provide written informed consent
- •Exclusion criteria:
- •Presence of significant medical disorder that would compromise the participant's safety to take part in the study such as cancer, immunosuppressed, or evidence of alcohol or substance abuse.
- •Wilson's disease or other disorder of copper metabolism.
- •Known hypersensitivity or allergy to any component of the product, or to acetaminophen.
- •Transcutaneous electrical nerve stimulation and use of crutches, walkers or wheel chairs should be excluded prior to and during treatment. Use of a cane is permitted.
- •Active conditions over the area to be treated such a eczema or psoriasis, compromised integrity of the intact, superficial skin layer over the area to be treated.
- •Pain in any joint being studied that could interfere with the subject's assessment of pain in the index joint.
- •Recent (within 12 months) injury (traumatic or sports related) to either knee causing pain and interference with daily activities such as walking.
- •Recent (within 12 months) surgery/procedure (including intra-articular injection) to either knee causing pain that could interfere with study assessments of pain, function, and QoL.
- •Extreme pain in the target knee characterized by POM score of </= 40 mm.
- •Mild pain in the target knee characterized by POM score of </= 40 mm.
- •Open surgery of he target knee within the last year.
- •Significant concomitant disease of the knee to be studied such as fracture or osteonecrosis.
- •Arthroscopic surgery of the target knee within the last 3 months.
- •Use of prohibited medications/therapies during he 7-9 day treatment period including:
- •Devices of therapeutics for knee pain or ambulation
- •Analgesics other than acetaminpohen
- •Systemic or locally injected corticosteroids
- •Other investigational drugs
- •Chemotherapy drugs
- •Immunotherapy
- •Topical products applied to he target knee
排除标准
- 未提供
研究组 & 干预措施
Experimental 3VM1001 3g x 4 daily
3VM1001 active cream administered 3g cream four times daily for seven days
干预措施: Experimental: 3VM1001 active 3g Cream 4 times daily (Drug)
Experimental 3VM1001 2g X 3 daily
3VM1001 active cream administered 2g cream three times daily for seven days
干预措施: Experimental: 3VM1001 active 2g Cream 3 times daily (Drug)
Placebo; 3VM1001 vehicle 2g X 3 daily
3VM1001 placebo vehicle administered 2g cream three times daily for seven days
干预措施: Placebo: 3VM1001 vehicle 2g Cream 3 times daily (Drug)
Experimental 3VM1001 3g X 3 daily
3VM1001 active cream administered 3g cream three times daily for seven days
干预措施: Experimental: 3VM1001 active 3g Cream 3 times daily (Drug)
Placebo; 3VM1001 vehicle 3g X3 daily
3VM1001 placebo vehicle administered 3g cream three times daily for seven day
干预措施: Placebo: 3VM1001 vehicle 3g Cream 3 times daily (Drug)
Placebo; 3VM1001 vehicle 3g X 4 daily
3VM1001 placebo vehicle administered 3g cream four times daily for seven days
干预措施: Placebo: 3VM1001 vehicle 3g Cream 4 times daily (Drug)
结局指标
主要结局
Time averaged change from baseline in a standard 100 mm Visual Analog Scale (VAS).
时间窗: 7 days
The time-averaged mean of all patient pain scores over each study period.
次要结局
- Patient global impression of change scale (PGIC) from baseline to end of study period.(8 days)
- Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of study.(8 days)
- Change in Patient Global Assessment of Treatment Satisfaction from baseline to end of study.(8 days)
- Use of rescue medication(8 days)
- Patient Global Impression of change from baseline in Osteoarthritis (OA) pain..(From screening Day 0 to the end of study (8 days))
- Adverse events, Serious adverse events, and study discontinuation(8 days)