At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 285 enrolled
Drug / intervention
HTX-011 +3 moredrug
Likely dose
Not stated in 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 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty
In Brief
A Phase 2 clinical trial evaluating HTX-011, Saline Placebo, and 2 other interventions for Postoperative Pain. Completed, enrolled 285 participants across 24 sites.
Detailed Summary
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartJan 2017
Primary CompletionApr 2018
Study CompletionMay 2018
TodayJul 2026
First PostedJan 10, 2017
Enrollment StartJan 13, 2017
Primary CompletionApr 20, 2018
Study CompletionMay 16, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.5 years ago
Interventions
HTX-011drug
HTX-011 (bupivacaine/meloxicam), via instillation
Saline Placebodrug
Saline placebo via injection
Bupivicaine HCldrug
Bupivacaine HCl without epinephrine
Ropivacainedrug
Ropivacaine, via injection