Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- Summary
- The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.
- Short title
- Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-12-15
- First posted
- 2022-09-23
- Registry last updated
- 2025-08-01
- Primary completion date
- 2023-12-15
- Start date
- 2022-10-03
- Actual participants
- 1,075
- Participants
- 1,075
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05553366
- ClinicalTrials.gov ID
- NCT05553366
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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
Timeframe: 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).
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
Timeframe: 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 baseline pain intensity score from the pain intensity score at each post dose 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).
Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo
Timeframe: From Baseline Up to 48 Hours After First Dose of Study Drug
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥ 2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline.
Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo
Timeframe: From Baseline Up to 48 Hours After First Dose of Study Drug
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS from baseline.
Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo
Timeframe: At 48 Hours After First Dose of Study Drug
The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported.
Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP
Timeframe: From Baseline up to Day 19
The percentage of participants with the events of vomiting or nausea during the specified time frame was reported.
Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo
Timeframe: 0 to 24 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 baseline pain intensity score from the pain intensity score at each post dose time point (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 to First Use of Rescue Medication, SUZ Compared to Placebo
Timeframe: 0 to 48 Hours After First Dose of Study Drug
Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication.
Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo
Timeframe: 0 to 48 Hours After First Dose of Study Drug
Total Rescue Medication Usage, SUZ Compared to Placebo
Timeframe: 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)
Timeframe: Day 1 up to Day 19
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
-
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
Key Exclusion Criteria:
-
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.
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