A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours.
研究概览
简要总结
The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the first metatarsal bone).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CL-108
CL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
干预措施: CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) (Drug)
Active Comparator: Norco
Commercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg
干预措施: Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) (Drug)
Placebo
CL-108 formulation without API
干预措施: Placebo (Drug)
结局指标
主要结局
The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours.
时间窗: 48 hours
The relief of moderate to severe pain, assessed by visual analog pain intensity scale, comparing CL-108 to placebo over 48 hours (SPID48).
时间窗: 48 hours
次要结局
- The severity of opioid-induced nausea, comparing CL-108 to Norco® over 48 hours(48 hours)
- The occurrence of vomiting, comparing CL-108 to Norco® over 48 hours(48 hours)
- The use of anti-emetics, comparing CL-108 to Norco® over 48 hours.(48 hours)
- The relief of post-operative nausea and vomiting (PONV), comparing CL-108 to placebo over 48 hours(48 hours)
- Incidence of post-discharge nausea and vomiting (PDNV), comparing CL-108 to placebo over days 3-5(48 hours)
- The relief of severe pain, comparing CL-108 to Norco® over 48 hours, i.e., summed pain intensity differences over 48 hours (SPID48)(48 hours)
研究者
Joseph Hazelton
Vice President, Regulatory Affairs
Charleston Laboratories, Inc