A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,075
- 试验地点
- 20
- 主要终点
- Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before Surgery
- •Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
- •After Surgery
- •Participant is lucid and able to follow commands
- •All analgesic guidelines were followed during and after the bunionectomy
排除标准
- •Before Surgery
- •Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
- •History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
- •Any prior surgery within 1 month before the first study drug dose
- •After Surgery
- •Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
- •Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
干预措施: Placebo (matched to SUZ) (Drug)
Placebo
Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
干预措施: Placebo (matched to HB/APAP) (Drug)
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
干预措施: HB/APAP (Drug)
Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
干预措施: Placebo (matched to SUZ) (Drug)
Suzetrigine (SUZ)
Participants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 2 days.
干预措施: SUZ (Drug)
Suzetrigine (SUZ)
Participants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 2 days.
干预措施: Placebo (matched to HB/APAP) (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) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo
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 subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 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 Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to HB/APAP(0 to 48 hours After First Dose of Study Drug)
- Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo(At 48 Hours After First Dose of Study Drug)
- Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo(0 to 48 Hours After First Dose of Study Drug)
- Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo(From Baseline Up to 48 Hours After First Dose of Study Drug)
- Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo(From Baseline Up to 48 Hours After First Dose of Study Drug)
- Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP(From Baseline up to Day 19)
- Time to First Use of Rescue Medication, SUZ Compared to Placebo(0 to 48 Hours After First Dose of Study Drug)
- Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo(0 to 24 Hours After First Dose of Study Drug)
- Total Rescue Medication Usage, SUZ Compared to Placebo(0 to 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 19)