A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale
研究概览
简要总结
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has given written informed consent to participate in the study in accordance with local regulations
- •Adult male and female participants ≥18 years of age at the time of screening
- •Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
- •Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
- •Pain from DPN present for at least 6 months
- •Haemoglobin A1C ≤11% at screening
- •Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening
排除标准
- •Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- •History of major depressive episode, active, significant psychiatric disorders
- •History of clinically significant drug or alcohol use disorder
- •History of neurolytic or neurosurgical therapy for DPNP
- •Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit
研究组 & 干预措施
Placebo
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
干预措施: LX9211 Matching Placebo (Drug)
LX9211 100 mg/10 mg
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
干预措施: LX9211 (Drug)
LX9211 200 mg/20 mg
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
干预措施: LX9211 (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale
时间窗: Baseline (Week 2 of the Run-in period) to Week 6
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
次要结局
- Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6(Baseline (Week 2 of the Run-in period) to Week 6)
- Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6(Baseline (Week 2 of the Run-in period) to Week 6)
- Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN(Baseline (Week 2 of the Run-in period) to Week 6)
- Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy(Baseline (Week 2 of the Run-in period) to Week 6)
- Patient Global Impression of Change (PGIC) Scale Score at Week 6(Baseline (Week 2 of the Run-in period) to Week 6)
- Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6(Weeks 6 to 11)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(First dose of study drug after randomization up to the end of study (up to Week 11))