A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

• Sponsor: Vertex Pharmaceuticals Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04977336
• Collaborator: (none)
• Enrollment: 274
• Locations: 12
• Arms: 3
• Actual Duration (Months): 7.5
• Patients Per Site: 22.8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: VX-548; Drug: HB/APAP; Drug: Placebo (matched to VX-548); Drug: Placebo (matched to HB/APAP)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
• Actual Study Start Date: Jul 19, 2021
• Actual Primary Completion Date: Feb 17, 2022
• Actual Study Completion Date: Mar 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VX-548 Participants will be randomized to receive different dose levels of VX-548.	Drug: VX-548; Tablets for oral administration.; Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.
Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP) Participants will receive HB/APAP.	Drug: HB/APAP; Capsules for oral administration.; Drug: Placebo (matched to VX-548); Placebo matched to VX-548 for oral administration.
Placebo Comparator: Placebo Participants will receive placebos matched to VX-548 and HB/APAP.	Drug: Placebo (matched to VX-548); Placebo matched to VX-548 for oral administration.; Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.

Outcome Measures

Primary Outcome Measures

1. Time-weighted sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug [0 to 48 Hours After the First Dose of Study Drug]

Secondary Outcome Measures

1. Time-weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug [0 to 24 Hours After the First Dose of Study Drug]

2. Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug [At 48 Hours After the First Dose of Study Drug]

3. Maximum Observed Plasma Concentration (Cmax) of VX-548 [Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug]

4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 [Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug]

5. Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 [Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug]

6. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Day 1 up to Day 18]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 and popliteal sciatic 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)

• Any prior surgery within 1 month before the first study drug

• 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 that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shoals Medical Trials Inc.	Sheffield	Alabama	United States	35660
2	Arizona Research Center	Phoenix	Arizona	United States	85053
3	Anaheim Clinical Trials	Anaheim	California	United States	92801
4	Lotus Clinical Research	Pasadena	California	United States	91105
5	New Hope Research Development	Tarzana	California	United States	91356
6	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
7	Chesapeake Research Group	Pasadena	Maryland	United States	21122
8	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
9	First Surgical Hospital	Bellaire	Texas	United States	77401
10	Legent Orthopedic Hospital	Carrollton	Texas	United States	75006
11	Endeavor Clinical Trials	San Antonio	Texas	United States	78229
12	JBR Clinical Research	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vertex Pharmaceuticals Incorporated
• ClinicalTrials.gov Identifier: NCT04977336
• Other Study ID Numbers: VX21-548-101
• First Posted: Jul 26, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain; Acetaminophen

Study Results

No Results Posted as of Apr 6, 2022