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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
243
Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.
Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
Participants received placebo matched to VX-150 and HB/APAP for 2 days.
Arizona Research Center
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Lotus Clinical Research
Pasadena, California, United States
Jean Brown Research
Salt Lake City, Utah, United States
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
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).
Time frame: 0 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 2 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). SPID22 was calculated from 2 to 24 hours and the score range was -220 (worst score) to 220 (best score).
Time frame: 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
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).
Time frame: 0 to 48 hours after the first dose
Time to Onset of Perceptible Pain Relief After the First Dose of VX-150 Versus Placebo
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Time to onset of perceptible pain relief (any pain relief at all after the first dose) reported based on the first stopwatch assessment.
Time frame: up to 6 hours after the first dose
Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo
Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the second stopwatch assessment.
Time frame: up to 6 hours after the first dose
Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo
Time to first rescue medication was the time elapsed from the first dose of VX-150 or placebo until the participants received the first dose of rescue medication.
Time frame: up to 48 hours after the first dose
Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo
Time frame: 0 to 24 hours after the first dose and 24 to 48 hours after the first dose
Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo
Total use of rescue medication was calculated as the sum of number of capsules multiplied by capsule strength at each dosing occasion of rescue medication. Rescue medication was ibuprofen (400 mg \[oral\] every 4 hours (q4h) as needed).
Time frame: 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)
Time frame: Day 1 and Day 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114
Time frame: 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
Time frame: Day 1 and Day 2
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 10