A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Pregabalin Sustained-Release Tablets for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 358
- 主要终点
- Numeric Rating Scale (NRS) mean change at week 13.
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled trial, the study was designed to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. The study includes a screening period (3 weeks, including baseline/run-in period), a treatment period (titration period, fixed dose period and withdrawal period), and a follow-up period. During the treatment period participants will receive pregabalin sustained-release tablets/placebo as daily treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years and ≤ 75 years at screening;
- •diagnosed with type 1 or type 2 diabetes for ≥ 1 year;
- •diagnosed with distal symmetrical polyneuropathy caused by diabetes (type 1 or type 2), with duration of neuropathic pain associated with diabetic peripheral neuropathy ≥ 6 months;
- •clearly understood and voluntarily participated in the study, and signed the informed consent form by themselves.
排除标准
- •Subjects with other conditions that may confound the assessment of Neuropathic Pain associated with Diabetic Peripheral neuropathy (DPNP), such as: neuropathic pain other than DPNP (cervical spondylosis, carpal tunnel syndrome, spinal stenosis, postherpetic pain, etc.), pain caused by other causes (gout, chronic obstructive arteriosclerosis, arthritis, etc.), and other pain at the assessment site (skin diseases and trauma);
- •subjects with known or suspected allergic reactions to various components of pregabalin sustained-release tablets or compounds closely related to paracetamol or paracetamol;
- •subjects with clinically significant or unstable diseases, such as but not limited to severe cardiovascular disease, cerebrovascular disease, liver, kidney, respiratory system, blood system, immune system diseases, inflammatory or rheumatic diseases, uncontrolled infection, untreated endocrine diseases, etc., and other conditions that judged by the investigator to influence participation in the trial;
- •subjects who have undergone renal transplantation, or are undergoing renal dialysis;
- •subjects with uncontrolled narrow-angle glaucoma, uncontrolled seizure history, or uncontrolled or poorly controlled hypertension;
- •Pregnant or lactating females or subjects planning to father a child during the trial (including males);
- •subjects with a history of drug or alcohol abuse within one year prior to screening; patients who, in the opinion of the investigator, are not suitable for participation in this trial.
研究组 & 干预措施
Experimental: pregabalin sustained-release tablets
干预措施: pregabalin sustained-release tablets (Drug)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) mean change at week 13.
时间窗: Week 13
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean of NRS (numeric rating scale) at week 13 will be recorded
次要结局
- NRS mean change at Weeks 1-12 and 14(Weeks 1-12 and 14)
- Proportion of subjects with NRS change(Week 13)
- Brief McGill Pain Questionnaire (SF-MPQ) score(Weeks 1, 5, 9, 13, and 14)
- Medical Outcomes Study Sleep Scale (MOS-SS) score(Weeks 1, 5, 9, 13, and 14)
- Hospital Anxiety and Depression Scale (HADS) score(Weeks 1, 5, 9, 13, and 14)
- Patient Global Impression of Improvement (PGIC) score(Weeks 1, 5, 9, 13, and 14)
- Clinical Global Impression of Improvement (CGIC) score(Weeks 1, 5, 9, 13, and 14)