A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 274
- Locations
- 12
- Primary Endpoint
- Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Before Surgery:
- •Participant 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
Exclusion Criteria
- •Before Surgery:
- •Prior history of bunionectomy or other foot surgery on the index foot
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •Any prior surgery within 1 month before the first study drug
- •After Surgery:
- •Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
Intervention: Placebo (matched to VX-548) (Drug)
Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
Intervention: Placebo (matched to HB/APAP) (Drug)
HB/APAP
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
Intervention: HB/APAP (Drug)
VX-548: Low Dose
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg tablet every 12 hours (q12h) for 2 days.
Intervention: VX-548 (Drug)
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
Intervention: 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.
Intervention: VX-548 (Drug)
Outcomes
Primary Outcomes
Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
Time Frame: 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). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Secondary Outcomes
- Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) 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 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 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 48 Hours After the First Dose of Study Drug(From Baseline at 48 Hours After First Dose of Study Drug)
- Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite)(Day 1 and Day 2)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite)(Day 1 and Day 2)
- Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite)(Day 1 and Day 2)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to Day 16)