Acute PainPhase 3NCT05558410
Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
A Phase 3 study testing Suzetrigine (SUZ) and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 12 sites in United States.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Suzetrigine (SUZ) and HB/APAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,118 participants
- Where
- 12 sitesUnited States
- Study dates
- 10 Oct 2022to 11 Sep 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Atlanta Center for Medical Research | Atlanta, GA
Atlanta, Georgia, 30331
HD Research LLC | First Surgical Hospital
Bellaire, Texas, 77401
Alliance Research Institute, LLC
Canoga Park, California, 91304
HD Research LLC | Houston Heights Hospital
Houston, Texas, 77008
Woodland International Research Group
Little Rock, Arkansas, 72211
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials
San Antonio, Texas, 78240
South Texas Spine & Surgical Hospital
San Antonio, Texas, 78258
Shoals Medical Trials Inc.
Sheffield, Alabama, 35660
New Hope Research Development
Tarzana, California, 91356
Kansas Spine and Specialty Hospital
Wichita, Kansas, 67226
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.
- Conditions
- Acute Pain
- Being tested
- Suzetrigine (SUZ), HB/APAP, Placebo (matched to SUZ), Placebo (matched to HB/APAP)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suzetrigine (SUZ)Drug
Also called VX-548
Tablets for oral administration.
HB/APAPDrug
Capsules for oral administration.
Placebo (matched to SUZ)Drug
Placebo matched to SUZ for oral administration.
Placebo (matched to HB/APAP)Drug
Placebo matched to HB/APAP for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours. Receives: Drug: Placebo (matched to SUZ); Drug: Placebo (matched to HB/APAP) |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | Active comparator | Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours. Receives: Drug: HB/APAP; Drug: Placebo (matched to SUZ) |
| Suzetrigine (SUZ) | Experimental | Participants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 48 hours. Receives: Drug: Suzetrigine (SUZ); Drug: Placebo (matched to HB/APAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 0 to 48 hours After First Dose of Study Drug
Secondary outcomes (10)
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
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).
Measured: 0 to 48 hours After First Dose of Study Drug
Time to Greater Than or Equal to (≥) 2-point Reduction in NPRS, SUZ Compared to Placebo
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.
Measured: From Baseline Up to 48 Hours After First Dose of Study Drug
Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo
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.
Measured: From Baseline Up to 48 Hours After First Dose of Study Drug
Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo
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.
Measured: At 48 hours
Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP
The incidence with the events of vomiting or nausea during the specified time frame was reported.
Measured: From Baseline Up to Day 19
Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo
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).
Measured: 0 to 24 Hours After First Dose of Study Drug
Time to First Use of Rescue Medication, SUZ Compared to Placebo
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.
Measured: 0 to 48 Hours After First Dose of Study Drug
Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo
Measured: 0 to 48 Hours After First Dose of Study Drug
Total Rescue Medication Usage, SUZ Compared to Placebo
Measured: 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)
Measured: Day 1 up to Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start10 Oct 2022
- Primary completion25 Aug 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558410
- Sponsor's protocol ID
- VX22-548-105
- Status last verified
- Jun 2025
- First submitted
- 23 Sep 2022
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Publications
Yuan S, Ji H, Lu Y, Zhang Z, Tang H. The Clinical Application of Suzetrigine. J Pain Palliat Care Pharmacother. 2026 Jun;40(2):311-320. doi: 10.1080/15360288.2026.2624502. Epub 2026 Feb 14.
PubMed 41689837