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Evaluation of 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: NCT05553366
Recruitment Status : Completed
First Posted : September 23, 2022
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of VX-548 for 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 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1075 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Actual Study Start Date : October 3, 2022
Actual Primary Completion Date : December 15, 2023
Actual Study Completion Date : December 15, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-548
Participants will be randomized to receive VX-548.
 Drug: VX-548
Tablets for oral administration.
Other Name: Suzetrigine

Drug: Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP)
Participants will be randomized to 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 be randomized to receive placebo 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
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Primary Outcome Measures :
  1. Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Compared to Placebo [ Time Frame: Baseline to 48 Hours ]

Secondary Outcome Measures :
  1. SPID48 Compared to HB/APAP [ Time Frame: Baseline to 48 Hours ]
  2. Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo [ Time Frame: Baseline to 48 Hours ]
  3. Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo [ Time Frame: Baseline to 48 Hours ]
  4. Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo [ Time Frame: At 48 Hours ]
  5. Incidence of Vomiting or Nausea Compared to HB/APAP [ Time Frame: Baseline to Day 17 ]
  6. Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo [ Time Frame: Baseline to 24 hours ]
  7. Time to First Use of Rescue Medication Compared to Placebo [ Time Frame: Baseline to 48 hours ]
  8. Proportion of Participants using Rescue Medication Compared to Placebo [ Time Frame: Baseline to 48 hours ]
  9. Total Rescue Medication Usage Compared to Placebo [ Time Frame: Baseline to 48 hours ]
  10. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Day 17 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Before Surgery

    • Participants 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 or other foot surgery on the index foot; or bunionectomy on the opposite foot
    • History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
    • Any prior surgery within 1 month before the first study drug dose

  • After Surgery

    • Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
    • Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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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): NCT05553366


Locations
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Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT05553366    
Other Study ID Numbers: VX22-548-104
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
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