Clinical trial NCT06619847: A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.


Eligibility criteria: Key Inclusion Criteria:

Before Surgery:

* Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block)

After Surgery:

* Participant is lucid and able to follow commands
* All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before Surgery:

* Prior history of bunionectomy or other foot surgery on the index foot
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years
* A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses

After Surgery:

* Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)
timeFrame: From 0 to 48 Hours After the First Dose of Study Drug
Secondary outcomes:
measure: Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours
timeFrame: At 48 Hours After the First Dose of Study Drug
measure: Proportion of Participants With >=50% Reduction in NPRS at 48 Hours
timeFrame: At 48 Hours After the First Dose of Study Drug
measure: Proportion of Participants With >=70% Reduction in NPRS at 48 Hours
timeFrame: At 48 Hours After the First Dose of Study Drug
measure: Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite
timeFrame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
measure: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite
timeFrame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite
timeFrame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 19
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Shoals Medical Trials Inc.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: Tarzana
country: United States
facility: New Hope Research Development | Tarzana, CA
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Bellaire
country: United States
facility: HD Research LLC | First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: HD Research LLC | Legent Orthopedic Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Village
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: