A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: VX-150; HB/APAP; Placebo
Intervention description: Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.; Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.; Participants received placebo matched to VX-150 and HB/APAP for 2 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study
      to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

        Prior to Surgery:

          -  Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive

          -  Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair,
             without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic
             block) not to include base wedge procedure

        After Surgery:

          -  Subject reported pain of ≥4 on the NPRS, and moderate or severe pain on the Verbal
             Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic
             block on Day 1

          -  Subject is lucid and able to follow commands

          -  All analgesic guidelines were followed during and after the bunionectomy

        Exclusion Criteria:

        Prior to Surgery:

          -  History in the past 10 years of malignancy, except for squamous cell skin cancer,
             basal cell skin cancer, and Stage 0 cervical carcinoma in situ

          -  History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

          -  History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN)

          -  History of peripheral neuropathy

          -  A known or clinically suspected infection with human immunodeficiency virus or
             hepatitis B or C viruses

          -  Prior medical history of bunionectomy or other foot surgery

          -  Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen

          -  For female subjects: Pregnant, nursing, or planning to become pregnant during the
             study or within 90 days after the last study drug dose

          -  For male subjects: Male subjects with a female partner who is pregnant, nursing, or
             planning to become pregnant during the study or within 90 days after the last study
             drug dose

        After Surgery:

          -  Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery
             such as hammertoe repair; or experienced medical complications during the bunionectomy
             that, in the opinion of the investigator, should preclude randomization

        Other protocol defined inclusion/exclusion criteria may apply.