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

NCT03206749 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2021-02-03

Study results available
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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.

Conditions

  • Acute Pain

Interventions

DRUG

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.

DRUG

HB/APAP

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2017-12-01
Completion
2017-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206749 on ClinicalTrials.gov