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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034952
Other study ID # VX21-548-102
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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