NCT06545097已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Full Abdominoplasty
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 4
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
详细描述
This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
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
- •Scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol.
- •Must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires.
排除标准
- •Any clinically significant disease, medical condition or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity or compromise the safety of the subject.
- •Subject has a current painful condition that could confound the interpretation of efficacy, safety or tolerability data in the study, in the opinion of the investigator.
- •History of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting.
研究组 & 干预措施
Treatment A
Experimental
Cebranopadol 400/400 ug (once daily)
干预措施: Cebranopadol (Drug)
Treatment B
Experimental
Cebranopadol 200 ug (once daily)
干预措施: Cebranopadol (Drug)
Treatment C
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Outcome Measure
时间窗: 4-48 hours
Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48)
次要结局
- Secondary Outcome Measure:(24-48 hours)
- Other Secondary Endpoint(peak sedation, total score and AUC4-48)
- Secondary Outcome Measure:(4-48 hours)
- Secondary Outcome Measure:(48 hours)
- Other Secondary Endpoint(Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours)
- Other Secondary Endpoint(Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36)
研究者
研究点 (4)
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