NCT00861445已完成2 期
A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 119
- 主要终点
- The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
研究概览
简要总结
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
- •Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
- •subjects must have good or fair diabetic control (Hgb A1c < 10%)
排除标准
- •Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.
- •Subject receives treatment for seizures.
- •Subject has had any amputations other than diabetically-related toe amputations.
- •Subject has major skin ulcers.
- •Subject has clinically significant ECG abnormalities.
- •Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
- •Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
- •At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
- •subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
研究组 & 干预措施
1
Experimental
干预措施: SPM927/Lacosamide (Drug)
2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
时间窗: Assessments throughout the trial, either daily and/or at clinic visits
次要结局
- Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)(Daily assessment during entire trial participation including visits at the site)
- Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)(Daily assessment during entire trial participation including visits at the site)
- Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)(Daily assessment during entire trial participation including visits at the site)
- Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)(Daily assessment during entire trial participation including visits at the site)
研究者
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