NCT05661734已完成3 期
A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 13
- 主要终点
- Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
- •Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS)
- •Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS
排除标准
- •Surgical participants:
- •History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed
- •History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study
- •History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Suzetrigine (SUZ)
Experimental
Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 up to Day 30
次要结局
- Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale(Day 14 or at Pain Resolution, whichever occurs first)
研究者
研究点 (13)
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