N of 1 Pilot Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse
研究概览
简要总结
This is a pilot study with a 4-period double-cross-over design evaluating a treatment with non-steroidal anti-inflammatory drugs (NSAIDs) in people with painful knee osteoarthritis.
详细描述
Once screened and found eligible, participants will be entered into an initial blinded 2-week treatment period of either naproxen or placebo and then entered into an open washout period of 2 weeks. At the end of this washout, participants will then receive either naproxen or placebo for a further 2 week period followed again by a 2 week washout. This sequence will then be repeated (total of 4 treatment periods) such that all participants receive naproxen for 2 treatment periods and placebo for 2 treatment periods. The order of treatment will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All medication will be prepared in capsules identical in appearance and weight.
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
- •Male or female >40 years of age
- •Meet ACR criteria for knee OA
- •Able and willing to provide informed consent
- •Average weekly pain in the index knee based on daily pain assessments of ≥ 4/10 and <9/10 on an 11-point NRS scale
- •Willing to discontinue current medications taken for OA pain
- •For women of child-bearing potential, willing to utilize some form of birth control or abstinence during the course of the study
- •If taking cannabinoids, have to be on a stable dose and have this maintained for the duration of the study
- •If receiving physical therapy or any non-pharmacologic modality(ies) for OA, these need to continue and remain stable for the duration of the study
- •Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed
- •Use of medications for knee OA pain on at least 4 out of 7 days per week
- •eDiary entries on at least 4 out 7 days per week during the observation period
- •Sub-Group Criterion (≥12 participants): Variability of average daily pain in the index knee during the observation period of ≥ 2 points on the NRS scale on at least 4 occasions
排除标准
- •History of intolerance or allergic reaction to NSAIDs
- •Previous history of GI bleed
- •Renal insufficiency resulting in serum creatinine > 1.5 mg/dL
- •History of myocardial infarction in last 6 months
- •Coexisting congestive heart failure or symptomatic atherosclerotic heart disease
- •Use of oral anticoagulants other than aspirin ≤ 325 mg for cardiac prophylaxis
- •Use of heparin or injectable anticoagulant
- •Uncontrolled hypertension
- •Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study
- •Use of recreational drugs
- •Fibromyalgia
- •Inflammatory arthropathies of any sort
- •Chronic back pain in which pain level is greater than the OA pain
- •Participation in another clinical trial other than one for covid or an observational and non-interventional study
- •Use of walker or other aid for walking other than a single cane
- •Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint
- •Index knee cannot have had previous joint replacement surgery
- •Arthroscopy within the past 6 months
- •Injection of hyaluronate in the index knee in the past 6 months
- •Corticosteroid injection in the index knee in the past 3 months
- •Injection of any biologic agent in the index in the past 12 months
- •Nerve ablation for the treatment of pain in the index knee
- •Any acute or chronic pain condition which would interfere with the evaluation of knee pain.
- •Pregnant, nursing or planning to become pregnant during length of study
研究组 & 干预措施
Cross-over Treatment: Initial treatment with naproxen
There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded.
干预措施: Naproxen 500 Mg (Drug)
Cross-over Treatment: Initial treatment with naproxen
There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded.
干预措施: Placebo (Drug)
Cross-over Treatment: Initial treatment with placebo
There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded.
干预措施: Naproxen 500 Mg (Drug)
Cross-over Treatment: Initial treatment with placebo
There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse
时间窗: baseline to end of 14 day treatment period
daily pain will be collected by a web application and averaged over a 7day period; higher scores imply more pain
次要结局
未报告次要终点
研究者
Thomas J. Schnitzer
Professor
Northwestern University