NCT03206749已完成2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 4
- 主要终点
- Time-weighted Sum of the Pain Intensity Difference (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose
研究概览
简要总结
This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study to evaluate the efficacy and safety of VX-150 in treating acute pain following 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior to Surgery:
- •Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive
- •Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure
- •After Surgery:
- •Subject reported pain of ≥4 on the NPRS, and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
- •Subject is lucid and able to follow commands
- •All analgesic guidelines were followed during and after the bunionectomy
排除标准
- •Prior to Surgery:
- •History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN)
- •History of peripheral neuropathy
- •A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
- •Prior medical history of bunionectomy or other foot surgery
- •Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen
- •For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
- •For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
- •After Surgery:
- •Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications 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
VX-150
Experimental
干预措施: VX-150 (Drug)
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
Active Comparator
干预措施: HB/APAP (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time-weighted Sum of the Pain Intensity Difference (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose
时间窗: 0 to 24 hours after the first dose
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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
次要结局
- Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo(up to 6 hours after the first dose)
- Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo(0 to 24 hours after the first dose and 24 to 48 hours after the first dose)
- Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 2 to 24 Hours After the First Dose(2 to 24 hours after the first dose)
- Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 0 to 48 Hours After the First Dose(0 to 48 hours after the first dose)
- Time to Onset of Perceptible Pain Relief After the First Dose of VX-150 Versus Placebo(up to 6 hours after the first dose)
- Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo(up to 48 hours after the first dose)
- Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo(0 to 24 hours after the first dose and 24 to 48 hours after the first dose)
- Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)(Day 1 and Day 2)
- Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114(Day 1 and Day 2)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114(Day 1 and Day 2)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 10)
研究者
研究点 (4)
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