A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

NCT05034952 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VX21-548-102
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the 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 pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

  0 to 48 Hours After First Dose of Study Drug

Secondary Outcomes (5)

• Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug

  0 to 24 Hours After First Dose of Study Drug

• Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug

  From Baseline At 48 Hours After First Dose of Study Drug

• Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug

  From Baseline At 48 Hours After First Dose of Study Drug

• Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug

  From Baseline at 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 16

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days.

Drug: Placebo (matched to VX-548); Drug: Placebo (matched to HB/APAP)

HB/APAP

ACTIVE COMPARATOR

Participants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days.

Drug: HB/APAP

VX-548: Low Dose

EXPERIMENTAL

Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days.

Drug: VX-548

VX-548: High Dose

EXPERIMENTAL

Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.

Drug: VX-548

Interventions

VX-548 DRUG

Tablets for oral administration.

Also known as: Suzetrigine

VX-548: High Dose; VX-548: Low Dose

HB/APAP DRUG

Capsules for oral administration.

HB/APAP

Placebo (matched to VX-548) DRUG

Placebo matched to VX-548 for oral administration.

Placebo

Placebo (matched to HB/APAP) DRUG

Placebo matched to HB/APAP for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Before Surgery:
• Participant scheduled to undergo an abdominoplasty without collateral procedures
• After Surgery:
• Participant is lucid and able to follow commands
• All analgesic guidelines were followed during and after the abdominoplasty
• Abdominoplasty procedure duration \<=3 hours without collateral procedures (for example., liposuction)

You may not qualify if:

• Before Surgery:
• Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
• Any prior surgery within 1 month before the first study drug
• After Surgery:
• Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
• Participant had collateral procedures during the abdominoplasty

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (7)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

• Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.

  PMID: 37530822 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: August 30, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 21, 2021
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)