A Double-blind, Placebo-controlled, Randomized, Parallel-group Study Evaluating the Efficacy and Tolerability of Oral BVT.115959, a Novel A2A Agonist, Versus Placebo in the Treatment of Diabetic Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Change in mean 24-hour pain intensity score from baseline using an 11-point Likert NRS assessed over the preceding 24 hours immediately upon awakening in the morning
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.
详细描述
The planned study is an exploratory study which aims to provide proof of the efficacy of BVT.115959 in the reduction of the symptoms of pain. Thus, the primary objective is to evaluate the anticipated analgesic properties of BVT.115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo.
The study will evaluate the efficacy and tolerability of oral BVT.115959 7 mg administered three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study and who are being maintained on stable analgesia throughout the study. Eligible subjects will be randomized in a ratio of 2:1 (BVT.115959: placebo).
The study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1 week follow-up 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
- 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
- •A diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months
- •Either no analgesic medication or on stable analgesic medication for at least 4 weeks
排除标准
- •Female patients who are fertile and of child-bearing potential
- •Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease
- •Painful conditions that may confound the evaluation of neuropathic pain
研究组 & 干预措施
BVT.115959
Capsules containing 7 mg BVT.115959 administered orally three times daily
干预措施: BVT.115959 (Drug)
Placebo
Placebo capsules administered orally three times daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in mean 24-hour pain intensity score from baseline using an 11-point Likert NRS assessed over the preceding 24 hours immediately upon awakening in the morning
次要结局
- Short-Form McGill Pain Questionnaire parameters
- Mood stability
- Present pain intensity using an 11-point Likert NRS assessed at bedtime
- Clinical Global Impression of Change and Patient's Global Impression of Change
- Quality of life
- Weekly mean sleep interference score
- Time to study withdrawal