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

Acute Pain Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034952
• Other study ID #: VX21-548-102
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: December 2022
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 21, 2021
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 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)

Key Exclusion Criteria

• 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

Other protocol defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• VX-548
Tablets for oral administration.
• HB/APAP
Capsules for oral administration.
• Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
• Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.

Locations

Country	Name	City	State
United States	First Surgical Hospital	Bellaire	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Lotus Clinical Research	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		0 to 48 Hours After the First Dose of Study Drug
Secondary	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 the First Dose of Study Drug
Secondary	Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug		At 48 Hours After the First Dose of Study Drug
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Day 17