NCT04707157终止2 期
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3556050 for the Treatment of Diabetic Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 34
- 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
This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) 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
- 18 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 pain medications taken for chronic pain conditions for the duration of the study.
- •Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
- •Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
- •Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
- •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 a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- •Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- •Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- •Have a positive human immunodeficiency virus (HIV) test result at screening.
- •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.
- •Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
- •Have known hereditary motor, sensory or autonomic neuropathies.
- •Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
- •Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
- •Are taking metformin therapy. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.
- •Have a history or presence of lactic acidosis.
- •Have a history or presence of severe hepatic disease including cirrhosis.
- •Have uncontrolled or unstable congestive heart failure.
- •Are taking carbonic anhydrase inhibitors if also taking metformin.
- •Have had a change in metformin therapy in the last 12 weeks.
- •Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
- •Are pregnant or breastfeeding.
- •Have fibromyalgia.
研究组 & 干预措施
600 Milligram (mg) LY3556050
Experimental
Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.
干预措施: LY3556050 (Drug)
Placebo
Placebo Comparator
Participants received placebo BID every 12 hours for up to 8 weeks.
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 8
The NRS was used 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
- Total Amount of Rescue Medication Use as Measured by Average Daily Dosage(Week 8)
- Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score(Baseline, Week 8)
- Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, Week 8)
- Change From Baseline for 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 Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep(Baseline, Week 8)
- Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)(Baseline, Week 8)
研究者
研究点 (34)
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