At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 243 enrolled
Drug / intervention
VX-150 +2 moredrug
Likely dose
VX-150 1500 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy
In Brief
A Phase 2 clinical trial evaluating VX-150, HB/APAP, and 1 other intervention for Acute Pain. Completed, enrolled 243 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJul 2017
Primary CompletionDec 2017
Study CompletionDec 2017
TodayJul 2026
First PostedJul 2, 2017
Enrollment StartJun 29, 2017
Primary CompletionDec 1, 2017
Study CompletionDec 8, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9 years ago
Interventions
VX-150drug
Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.
HB/APAPdrug
Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
Placebodrug
Participants received placebo matched to VX-150 and HB/APAP for 2 days.