NCT01890902撤回3 期
A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8.
研究概览
简要总结
The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of OA of the knee according to the ACR criteria.
- •Kellgren-Lawrence grade 2-3 disease
- •Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication.
排除标准
- •Total knee replacement surgery tentatively scheduled within next 6 months.
- •Palpable knee effusion.
- •Significant pain outside the target knee, including significant hip, back, or contralateral knee pain.
- •Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability.
- •History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia.
- •History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years.
- •Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening.
- •Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.
研究组 & 干预措施
Impracor (Ketoprofen 10% Cream)
Experimental
Topical Cream over a period of 14 days
干预措施: Ketoprofen 10% Cream (Drug)
Placebo Cream:
Placebo Comparator
Topical Cream over a period of 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8.
时间窗: Day 4, 6 and 8
次要结局
- Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8.(Day 8)
研究者
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