NCT05036174Unknown不适用
Diphenhydramine 5% Ointment for Pain in Knee Osteoarthritis: a Randomised Double-blind Placebo-controlled Pilot Feasibility Study
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rates
研究概览
简要总结
The main purpose of this study is to evaluate whether recruitment rates are adequate to power a future RCT. The secondary aims are to obtain preliminary information about safety and efficacy of topical diphenhydramine 5% ointment in patients with knee OA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACR clinical criteria of knee OA
- •Radiographic knee OA (Kellgren-Lawrence grade >1)
- •Age ≥ 50 years
- •VAS pain >= 40/100 mm at baseline
- •Non-use of NSAIDs one week before the baseline
- •Symptoms present on most days for at least 3 months
排除标准
- •Any form of inflammatory arthritis
- •Use of another topical product at the application site
- •Treatment with intraarticular hyaluronic acid within 6 months
- •Treatment with intraarticular glucocorticoid within 2 months
- •Knee injury/surgery or diagnostic arthroscopy within 3 months
- •Allergic reaction to diphenhydramine or any component of the formulation
- •Participant has clinical signs and symptoms suggestive of COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening
研究组 & 干预措施
Diphenhydramine
Experimental
Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days
干预措施: Diphenhydramine 5% (Drug)
Placebo
Placebo Comparator
Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Recruitment rates
时间窗: through study completion, an average of 1 year
Ability to recruit 8 patients per month
次要结局
- Refusal rate(through study completion, an average of 1 year)
- Adherence(through study completion, an average of 1 year)
- Visual Analogue Scale for Pain(Baseline to week 1)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain(Baseline to week 1)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms(Baseline to week 1)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)(Baseline to week 1)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec)(Baseline to week 1)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL)(Baseline to week 1)
- Visual Analogue Scale for patient global assessment(Baseline to week 1)
- Global evaluation of treatment by patient(Baseline to week 1)
- Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain(Week 1)
- Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment(Week 1)
- Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living(Week 1)
- Adverse events(Baseline to Week 1)
研究者
Ivan Shirinsky, MD, PhD
Head of the laboratory of immunopharmacology
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
研究点 (1)
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