At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 412 enrolled
Drug / intervention
HTX-011 +4 moredrug
Likely dose
HTX-011 60 mgfrom 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 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy
In Brief
A Phase 3 clinical trial evaluating HTX-011, Saline Placebo, and 3 other interventions for Postoperative Pain. Completed, enrolled 412 participants across 15 sites.
Detailed Summary
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionJan 2018
Study CompletionMar 2018
TodayJul 2026
First PostedSep 28, 2017
Enrollment StartOct 24, 2017
Primary CompletionJan 8, 2018
Study CompletionMar 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.8 years ago
Interventions
HTX-011drug
HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation
Saline Placebodrug
Saline placebo by instillation
Bupivacaine HCldrug
Bupivacaine HCl without epinephrine, 50 mg by injection
Luer-lock applicatordevice
Applicator for instillation
Vial access devicedevice
Device for withdrawal of drug product