NCT07377721招募中1 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Pregabalin Capsule Controlled, Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2026年3月24日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4.
研究概览
简要总结
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
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
- •Able and willing to provide a written informed consent.
- •Males or females aged ≥18years of age inclusive.
- •Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
- •HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
- •At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and < 90 mm.
排除标准
- •Subjects with a history of severe allergies.
- •Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).
- •Subjects with abnormal liver and renal function.
- •Corrected QT Interval (QTc): > 450 ms (male), > 470 ms (female).
- •Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of diabetic peripheral neuropathic pain (DPNP).
- •History of suicidal behavior or attempted suicide.
- •Participated in another clinical study within 3 months prior to screening.
研究组 & 干预措施
Blank Preparation Placebo Group
Placebo Comparator
干预措施: HRS-2129 Placebo (Drug)
Blank Preparation Placebo Group
Placebo Comparator
干预措施: Pregabalin Capsules Placebo (Drug)
Pregabalin Group
Active Comparator
干预措施: Pregabalin Capsules (Drug)
HRS-2129 High Dose Group
Experimental
干预措施: HRS-2129 Tablets (Drug)
HRS-2129 High Dose Group
Experimental
干预措施: HRS-2129 Placebo (Drug)
HRS-2129 High Dose Group
Experimental
干预措施: Pregabalin Capsules Placebo (Drug)
HRS-2129 Low Dose Group
Experimental
干预措施: HRS-2129 Placebo (Drug)
HRS-2129 Low Dose Group
Experimental
干预措施: Pregabalin Capsules Placebo (Drug)
HRS-2129 Low Dose Group
Experimental
干预措施: HRS-2129 Tablets (Drug)
Pregabalin Group
Active Comparator
干预措施: HRS-2129 Placebo (Drug)
结局指标
主要结局
Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4.
时间窗: Baseline and Week 4.
The mean change in Average Daily Pain Score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]). The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
次要结局
- Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline).(Baseline and Week 4.)
- Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 4.(From Week 1 to Week 4.)
- Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4.(Baseline and Week 4.)
- Population Pharmacokinetics (PopPK) characteristics of HRS-2129 in Chinese patients with diabetic peripheral neuropathic pain - Serum concentration of HRS-2129.(From Day 0 to Day 30.)
- Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HRS-2129 and placebo at Week 4.(Baseline and Week 4.)
- Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4.(At Week 4.)
- Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HRS-2129 and placebo at Week 4.(Baseline and Week 4.)
- Number and severity of serious adverse events (SAEs).(From Week 1 to Week 6.)
- Number and severity of adverse events (AEs).(From Week 1 to Week 6.)
研究者
研究点 (2)
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