Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: Placebo (matched to SUZ); Drug: HB/APAP; Drug: Suzetrigine (SUZ); Drug: VX-548; Drug: Placebo (matched to HB/APAP); Drug: Placebo (matched to VX-548)

• Registration Number: NCT05558410
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2022-10-10
• Primary Completion: 2023-08-25
• Study Completion: 2023-09-11
• Disposition First Submitted: 2024-08-23
• Status Verified: 2025-06
• Results First Submitted: 2025-06-11
• Results First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Results First Posted: 2025-07-01
• Disposition First Posted: 2025-07-01
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (matched to SUZ)	Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.
Placebo	Placebo (matched to HB/APAP)	Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	HB/APAP	Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	Placebo (matched to SUZ)	Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.
Suzetrigine (SUZ)	Suzetrigine (SUZ)	Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 48 hours.
Suzetrigine (SUZ)	Placebo (matched to HB/APAP)	Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 48 hours.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	HB/APAP	Participants will receive HB/APAP.
Hydrocodone bitartrate/acetaminophen (HB/APAP)	Placebo (matched to VX-548)	Participants will receive HB/APAP.
VX-548	VX-548	Participants will receive VX-548.
VX-548	Placebo (matched to HB/APAP)	Participants will receive VX-548.
Placebo	Placebo (matched to VX-548)	Participants will receive placebos matched to VX-548 and HB/APAP.
Placebo	Placebo (matched to HB/APAP)	Participants will receive placebos matched to VX-548 and HB/APAP.

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo	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	From Baseline Up to Day 19	The incidence with the events of vomiting or nausea during the specified time frame was reported.
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	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	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	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.
Time to First Use of Rescue Medication, SUZ Compared to Placebo	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	0 to 48 Hours After First Dose of Study Drug
Total Rescue Medication Usage, SUZ Compared to Placebo	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)	Day 1 up to Day 19
Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo	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).

Trial Locations

Locations (12)

Shoals Medical Trials Inc.; 🇺🇸 Sheffield, Alabama, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Alliance Research Institute, LLC; 🇺🇸 Canoga Park, California, United States

New Hope Research Development; 🇺🇸 Tarzana, California, United States

Atlanta Center for Medical Research | Atlanta, GA; 🇺🇸 Atlanta, Georgia, United States

Kansas Spine and Specialty Hospital; 🇺🇸 Wichita, Kansas, United States

HD Research LLC | First Surgical Hospital; 🇺🇸 Bellaire, Texas, United States

HD Research LLC | Houston Heights Hospital; 🇺🇸 Houston, Texas, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

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