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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

Tracking Information
First Submitted Date  ICMJE July 15, 2021
First Posted Date  ICMJE July 26, 2021
Last Update Posted Date April 6, 2022
Actual Study Start Date  ICMJE July 19, 2021
Actual Primary Completion Date February 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Drug: VX-548
    Tablets for oral administration.
  • Drug: HB/APAP
    Capsules for oral administration.
  • 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.
Study Arms  ICMJE
  • Experimental: VX-548
    Participants will be randomized to receive different dose levels of VX-548.
    Interventions:
    • Drug: VX-548
    • Drug: Placebo (matched to HB/APAP)
  • Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP)
    Participants will receive HB/APAP.
    Interventions:
    • Drug: HB/APAP
    • Drug: Placebo (matched to VX-548)
  • Placebo Comparator: Placebo
    Participants will receive placebos matched to VX-548 and HB/APAP.
    Interventions:
    • Drug: Placebo (matched to VX-548)
    • Drug: Placebo (matched to HB/APAP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2022)
274
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2021)
270
Actual Study Completion Date  ICMJE March 4, 2022
Actual Primary Completion Date February 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04977336
Other Study ID Numbers  ICMJE VX21-548-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Vertex Pharmaceuticals Incorporated
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP