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

Vertex Pharmaceuticals Incorporated1,118 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,118

Conditions

Acute Pain

Interventions

Suzetrigine (SUZ)DRUG

Tablets for oral administration.

HB/APAPDRUG

Capsules for oral administration.

Placebo (matched to SUZ)DRUG

Placebo matched to SUZ for oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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).

Time frame: 0 to 48 hours After First Dose of Study Drug

Secondary Outcomes

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).

Time frame: 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.

Time frame: From Baseline Up to 48 Hours After First Dose of Study Drug

Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo

Data from ClinicalTrials.gov

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Placebo matched to HB/APAP for oral administration.

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

...and 2 more locations

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 frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: 0 to 48 Hours After First Dose of Study Drug

Total Rescue Medication Usage, SUZ Compared to Placebo

Time frame: 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)

Time frame: Day 1 up to Day 19