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Purpose

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 block) - After Surgery: - Participant is lucid and able to follow commands - All analgesic guidelines were followed during and after the bunionectomy

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) within the last 2 years - A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses - 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 Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-993 		Participants will be randomized to receive different dose levels of VX-993.
  • Drug: VX-993
    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-993)
    Placebo matched to VX-993 for oral administration.
Placebo Comparator
Placebo 		Participants will be randomized to receive placebos matched to VX-993 and HB/APAP.
  • Drug: Placebo (matched to VX-993)
    Placebo matched to VX-993 for oral administration.
  • Drug: Placebo (matched to HB/APAP)
    Placebo matched to HB/APAP for oral administration.

Recruiting Locations

Memorial Hermann Village
Houston, Texas 77043

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.