NCT00878293已完成2 期
A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy
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
- 90
- 试验地点
- 4
- 主要终点
- Average daily pain intensity
研究概览
简要总结
The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.
排除标准
- •Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
- •non Caucasian or Hispanic.
- •Concomitant painful disease.
- •Life-long history of seizure disorder or epilepsy.
- •Subjects with clinical relevant cardiac and vascular diseases.
- •Subjects with impaired renal function
- •Subjects with impaired hepatic function
- •Female subjects who are pregnant or breastfeeding.
研究组 & 干预措施
H
Active Comparator
Morphin
干预措施: MS Continus® (Drug)
G
Experimental
Dose 7
干预措施: GRT6005 (Drug)
A
Experimental
Dose 1, 40 µg
干预措施: GRT6005 (Drug)
B
Experimental
Dose 2, 120 µg
干预措施: GRT6005 (Drug)
C
Experimental
Dose 3
干预措施: GRT6005 (Drug)
D
Experimental
Dose 4
干预措施: GRT6005 (Drug)
E
Experimental
Dose 5
干预措施: GRT6005 (Drug)
F
Experimental
Dose 6
干预措施: GRT6005 (Drug)
I
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Average daily pain intensity
时间窗: 5 days
次要结局
- Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values(5 days)
研究者
研究点 (4)
Loading locations...
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