CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 418 enrolled
Drug / intervention
HTX-011 +4 moredrug
Likely dose
HTX-011 300 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.

Search/NCT03237481
NCT03237481Phase 3Completed
CompareCT.gov

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 Open Inguinal Herniorrhaphy

Heron Therapeutics·interventional·Posted Aug 2, 2017·Updated Mar 2, 2026

In Brief

A Phase 3 clinical trial evaluating HTX-011, Bupivacaine HCl, and 3 other interventions for Postoperative Pain. Completed, enrolled 418 participants across 24 sites in 2 countries.

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 unilateral open inguinal herniorrhaphy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesBelgium, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2, 2017
Enrollment StartJul 31, 2017
Primary CompletionDec 22, 2017
Study CompletionJan 16, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago

Interventions

HTX-011drug

HTX 011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation

Bupivacaine HCldrug

Bupivacaine HCl without epinephrine, 75 mg by injection

Saline placebodrug

Saline placebo by instillation

Luer-lock applicatordevice

Applicator for instillation

Vial access devicedevice

Device for withdrawal of drug product