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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04977336
Recruitment Status : Completed
First Posted : July 26, 2021
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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

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Study Type : Interventional  (Clinical Trial)
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 : July 19, 2021
Actual Primary Completion Date : February 17, 2022
Actual Study Completion Date : March 4, 2022

Resource links provided by the National Library of Medicine


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.




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At 48 Hours After the First Dose of Study Drug ]
  3. Maximum Observed Plasma Concentration (Cmax) of VX-548 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 1 up to Day 18 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977336


Locations
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United States, Alabama
Shoals Medical Trials Inc.
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85053
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Lotus Clinical Research
Pasadena, California, United States, 91105
New Hope Research Development
Tarzana, California, United States, 91356
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Texas
First Surgical Hospital
Bellaire, Texas, United States, 77401
Legent Orthopedic Hospital
Carrollton, Texas, United States, 75006
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
United States, Utah
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT04977336    
Other Study ID Numbers: VX21-548-101
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics