NCT00872885已完成2 期
A Randomized, Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Moderate to Severe Pain Following Bunionectomy.
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
- 258
- 试验地点
- 1
- 主要终点
- Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
研究概览
简要总结
The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy
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.
- •Concomitant inflammatory disease.
- •Life-long history of seizure disorder or epilepsy.
- •Subjects with impaired renal function
- •Subjects with impaired hepatic function
- •Female subjects who are pregnant or breastfeeding.
- •Resting pulse rate is <50bpm or >100 bpm after 5 minutes rest in supine position
- •resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is <100mmHg or >140 mmHg Diastolic blood pressure is <60 mmHg or > 90 mmHg
研究组 & 干预措施
A
Experimental
Dose 1
干预措施: GRT6005 (Drug)
B
Experimental
Dose 2
干预措施: GRT6005 (Drug)
C
Experimental
Dose 3
干预措施: GRT6005 (Drug)
D
Active Comparator
Morphine
干预措施: Morphine (Drug)
E
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
时间窗: 8 hours
次要结局
- Time to first rescue medication(24 hours)
- Patient Global Impression of Change(24 hours)
- Amount of rescue medication(24 hours)
- Adverse events(24 hours)
研究者
研究点 (1)
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