A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
研究概览
简要总结
This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth.
A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Determination of being likely or possibly nausea-prone.
- •Male or non-pregnant and non-lactating female.
- •Surgical extraction of at least 2 impacted third molar teeth
- •A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control.
- •Surgical extraction of at least 2 impacted third molar teeth.
- •Presence of at least moderate post-operative pain.
排除标准
- •Medial Condition, presence of a serious medical condition.
- •Active local infection.
- •Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.
- •Caffeine use since midnight before the operation.
- •Use of an IND Drug within past 30 days.
- •Previous participation in this study.
- •Pregnant or lactating.
- •Employee of the PI,sub-investigator or Charleston Labs or relative of an employee.
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 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) (Drug)
Norco
Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
干预措施: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) (Drug)
Placebo
CL-108 formulation without API
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
时间窗: Over the first 24 hours
After data has been locked.
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
时间窗: over 24 hours (SPID24)
After data has been locked.
次要结局
- Reduction of vomiting in patients treated with an opioid-containing pain reliever.(over 6 hours)
- Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.(over 6 hours)