A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 7
- 主要终点
- Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.
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
- •Before Surgery:
- •Participant scheduled to undergo an abdominoplasty without collateral procedures
- •After Surgery:
- •Participant is lucid and able to follow commands
- •All analgesic guidelines were followed during and after the abdominoplasty
- •Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction)
- •Key Exclusion Criteria
- •Before Surgery:
- •Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •Any prior surgery within 1 month before the first study drug
- •After Surgery:
- •Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
- •Participant had collateral procedures during the abdominoplasty
- •Other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days.
干预措施: Placebo (matched to VX-548) (Drug)
Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days.
干预措施: Placebo (matched to HB/APAP) (Drug)
HB/APAP
Participants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days.
干预措施: HB/APAP (Drug)
VX-548: Low Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days.
干预措施: VX-548 (Drug)
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
干预措施: VX-548 (Drug)
结局指标
主要结局
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
时间窗: 0 to 48 Hours After First Dose of Study Drug
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
次要结局
- Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug(0 to 24 Hours After First Dose of Study Drug)
- Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug(From Baseline At 48 Hours After First Dose of Study Drug)
- Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug(From Baseline At 48 Hours After First Dose of Study Drug)
- Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug(From Baseline at 48 Hours After First Dose of Study Drug)
- Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 up to Day 16)