NCT05080660已完成2 期
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Osteoarthritis Pain
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 27
- 主要终点
- Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to test safety and efficacy of study drug LY3526318 in for the treatment of knee pain due to with osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
- •Have a history of daily pain for at least 12 weeks based on participant report or medical history.
- •Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
- •Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
- •Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
- •Have presence of index knee pain for >12 weeks at screening.
- •Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.
- •Are men, or women able to abide by reproductive and contraceptive requirements.
排除标准
- •Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
- •Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
- •Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- •Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- •Have fibromyalgia
- •Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- •Have a positive human immunodeficiency virus (HIV) test result at screening.
- •Are in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- •Have an intolerance to acetaminophen or paracetamol or any of its excipients.
- •Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
- •Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.
- •Have presence of surgical hardware or other foreign body in the index knee.
- •Have an unstable index joint (such as a torn anterior cruciate ligament).
- •Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.
- •Have chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
- •Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
- •Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.
- •Have a history of infection in the index joint.
- •Have a history of arthritis due to crystals (e.g., gout, pseudo gout).
- •Have pain or functional impairment due to ipsilateral hip osteoarthritis.
- •Are pregnant or breastfeeding.
研究组 & 干预措施
LY3526318
Experimental
Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.
干预措施: LY3526318 (Drug)
Placebo
Placebo Comparator
Participants received placebo orally, once daily, for 8-weeks treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
时间窗: Baseline, Week 4
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
次要结局
- Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale(Baseline, Week 8)
- Change From Baseline on the WOMAC® Stiffness Subscale(Baseline, Week 8)
- Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep(Baseline, Week 8)
- Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)(Baseline, Week 8)
- Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change(Baseline, Week 8)
- Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline, Week 8)
- Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)(Baseline, Week 8)
- Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, Week 8)
- Total Amount of Rescue Medication Use as Measured by Average Daily Dosage(Week 8)
- Change From Baseline on the WOMAC® Physical Function Subscale(Baseline, Week 8)
研究者
研究点 (27)
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