A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2017-12-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VX-150

Group Type EXPERIMENTAL

VX-150

Intervention Type DRUG

Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.

Hydrocodone Bitartrate/Acetaminophen (HB/APAP)

Group Type ACTIVE_COMPARATOR

HB/APAP

Intervention Type DRUG

Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants received placebo matched to VX-150 and HB/APAP for 2 days.

Interventions

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VX-150

Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.

Intervention Type DRUG

HB/APAP

Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.

Intervention Type DRUG

Placebo

Participants received placebo matched to VX-150 and HB/APAP for 2 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No