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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2023-09-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery

NCT04229420

Pain Postoperative

COMPLETED NA

The Goal of This Study is to Evaluate the Effect of Ultrasound Guided Erector Spinae Plane Block on Postoperative Pain After Major Abdominal Surgeries

NCT04382209

Postoperative Pain

UNKNOWN NA

Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty

NCT06845215

Abdominoplasty Postoperative Pain Transversus Abdominis Plane (TAP) Block +1 more

RECRUITING

Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block in Thoractomy

NCT06856538

Thoracic Pain

RECRUITING NA

Transversus Abdominis Plan Block Versus Rectus Sheath Block

NCT06897345

Abdominal Obesity Postoperative Pain Postoperative Complications

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.

Group Type PLACEBO_COMPARATOR

Placebo (matched to SUZ)

Intervention Type DRUG

Placebo matched to SUZ for oral administration.

Placebo (matched to HB/APAP)

Intervention Type DRUG

Placebo matched to HB/APAP for oral administration.

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.

Group Type ACTIVE_COMPARATOR

HB/APAP

Intervention Type DRUG

Capsules for oral administration.

Placebo (matched to SUZ)

Intervention Type DRUG

Placebo matched to SUZ for oral administration.

Suzetrigine (SUZ)

Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 48 hours.

Group Type EXPERIMENTAL

Suzetrigine (SUZ)

Intervention Type DRUG

Tablets for oral administration.

Placebo (matched to HB/APAP)

Intervention Type DRUG

Placebo matched to HB/APAP for oral administration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Suzetrigine (SUZ)

Tablets for oral administration.

Intervention Type DRUG

HB/APAP

Capsules for oral administration.

Intervention Type DRUG

Placebo (matched to SUZ)

Placebo matched to SUZ for oral administration.

Intervention Type DRUG

Placebo (matched to HB/APAP)

Placebo matched to HB/APAP for oral administration.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VX-548

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No