Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
- Summary
- The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.
- Short title
- Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-09-11
- First posted
- 2022-09-28
- Registry last updated
- 2025-07-01
- Primary completion date
- 2023-08-25
- Start date
- 2022-10-10
- Actual participants
- 1,118
- Participants
- 1,118
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05558410
- ClinicalTrials.gov ID
- NCT05558410
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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 by 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. Participants who did not reach at least a 2-point reduction in NPRS from baseline by 48 hours were censored at 48 hours.
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 scores from baseline. Participants who did not reach at least a 1-point reduction in NPRS from baseline by 48 hours were censored at 48 hours.
Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo
Timeframe: At 48 hours
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. Participants who discontinued study drug or had missing PGA at 48 hours were considered to not have reported good or excellent on the PGA.
Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP
Timeframe: From Baseline Up to Day 19
The incidence 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 (PID) was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (NPRS range: 0 = no pain to 10 = worst possible pain). Time-weighted SPID was calculated as the sum of the PIDs at each post-dose time point multiplied by the time interval (in hours) between each time point. SPID 24 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. Participants who did not take any rescue medication within 48 hours were censored at 48 hours.
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
- Participant scheduled to undergo a standard ("full") abdominoplasty procedure
-
After Surgery
- Participant is lucid and able to follow commands and able to swallow oral medications
- All analgesic guidelines were followed during and after the abdominoplasty
- Abdominoplasty procedure duration less than or equal to (≤3) hours
Key Exclusion Criteria:
-
Before Surgery
- Prior history of abdominoplasty
- History of Intra-abdominal and/or pelvic surgery that resulted into complications
- 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 non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
- Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
- Shoals Medical Trials Inc.Sheffield, United States
- Arizona Research CenterPhoenix, United States
- Woodland International Research GroupLittle Rock, United States
- Alliance Research Institute, LLCCanoga Park, United States
- New Hope Research DevelopmentTarzana, United States
- Atlanta Center for Medical Research | Atlanta, GAAtlanta, United States
- Kansas Spine and Specialty HospitalWichita, United States
- HD Research LLC | First Surgical HospitalBellaire, United States
- HD Research LLC | Houston Heights HospitalHouston, United States
- Endeavor Clinical TrialsSan Antonio, United States
- South Texas Spine & Surgical HospitalSan Antonio, United States
- JBR Clinical ResearchSalt Lake City, United States
- PubMed 41689837Related publication