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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05553366
Recruitment Status : Recruiting
First Posted : September 23, 2022
Last Update Posted : January 5, 2023
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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VX-548
Participants will be randomized to receive 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 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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


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


Contacts
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Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

Locations
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United States, Alabama
Shoals Medical Trials Inc. Recruiting
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85053
United States, Arkansas
Woodland International Research Group Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Anaheim Clinical Trials Recruiting
Anaheim, California, United States, 92801
Trovare Clinical Research Recruiting
Bakersfield, California, United States, 93301
New Hope Research Development Recruiting
Tarzana, California, United States, 91356
New Hope Research Development Recruiting
West Covina, California, United States, 91790
United States, Florida
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
United States, Ohio
Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
United States, Texas
HD Research LLC | First Surgical Hospital Recruiting
Bellaire, Texas, United States, 77401
HD Research LLC | Legent Orthopedic Hospital Recruiting
Carrollton, Texas, United States, 75006
HD Research LLC | Houston Heights Hospital Recruiting
Houston, Texas, United States, 77008
Futuro Clinical Trials Recruiting
McAllen, Texas, United States, 78501
Endeavor Clinical Trials Active, not recruiting
San Antonio, Texas, United States, 78240
United States, Utah
JBR Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Wasatch Clinical Research | Salt Lake City, UT Recruiting
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: NCT05553366    
Other Study ID Numbers: VX22-548-104
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: December 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