A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Time-interval weighted summed pain intensity (SPI) at designated time points
研究概览
简要总结
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.
详细描述
This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.
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)
盲法说明
The sponsor, the investigator, personnel at the clinical study unit who are directly involved with monitoring and/or performing study procedures and assessments, and the subjects will be blinded to treatment assignment
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
- •Male or female, ≥ 18 years of age.
- •Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).
- •Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
- •Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.
排除标准
- •Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
- •Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
- •History of deep vein thrombosis or factor V Leiden deficiency.
- •History of syncope or other syncopal attacks.
- •Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
- •Evidence of a clinically significant 12-lead ECG abnormality.
研究组 & 干预措施
DMTS Patch
DMTS applied to upper outer arm
干预措施: DMTS Patch (Drug)
Placebo Patch
Placebo system (with no drug) to match DMTS applied to the upper arm
干预措施: Placebo Patch (Drug)
结局指标
主要结局
Time-interval weighted summed pain intensity (SPI) at designated time points
时间窗: 5 to 96 hours following surgery
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain
次要结局
- Time-interval weighted summed pain intensity (SPI) over various time intervals(5 to 96 hours following surgery)
- Rescue Medication(Up to 96 hours post surgery)
- Rescue Medication units(Up to 96 hours post surgery)
- Integrated Pain score and Rescue Medication(Up to 96 hours post surgery)