NCT06203002已完成2 期
A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 108
- 主要终点
- Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
研究概览
简要总结
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
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 Screening Visit
- •Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening
- •Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
- •Pain from DPNP present for at least 6 months prior to Screening
- •At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
- •Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
- •Willing to adhere to the prohibitions and restrictions specified in the protocol.
排除标准
- •Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- •History of neurolytic or neurosurgical therapy for DPNP
- •Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
- •Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
- •Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
研究组 & 干预措施
LX9211 Low Dose
Experimental
LX9211 low dose, orally, once daily during a blinded treatment period.
干预措施: LX9211 (blinded) (Drug)
LX9211 High Dose
Experimental
LX9211 high dose, orally, once daily during a blinded treatment period.
干预措施: LX9211 (blinded) (Drug)
LX9211 High Dose Followed by Low Dose
Experimental
LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
干预措施: LX9211 (blinded) (Drug)
LX9211 Placebo
Placebo Comparator
LX9211 matching placebo, orally, once daily during a blinded treatment period.
干预措施: Placebo (blinded) (Drug)
结局指标
主要结局
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
时间窗: Baseline, Week 8
ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
次要结局
- Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score(Baseline, Week 8)
- Patient Global Impression of Change (PGIC) Score at Week 8(Week 8)
- Change from Baseline to Week 8 in Pain Interference on Sleep(Baseline, Week 8)
- Change from Baseline to Week 8 in Burning Pain(Baseline, Week 8)
研究者
研究点 (108)
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