CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
HTX-011 +3 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.

Search/NCT03718039
NCT03718039Phase 2Completed
CompareCT.gov

A Phase 2 Open-Label Study of HTX-011 Via Individualized Dosing Administration for Postoperative Analgesia Following Unilateral Simple Bunionectomy

Heron Therapeutics·interventional·Posted Oct 24, 2018·Updated Mar 2, 2026

In Brief

A Phase 2 clinical trial evaluating HTX-011, Luer Lock applicator, and 2 other interventions for Postoperative Pain. Completed, enrolled 78 participants across 1 site.

Detailed Summary

This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartOct 24, 2018
Primary CompletionJan 31, 2019
Study CompletionMar 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.7 years ago

Interventions

HTX-011drug

HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.

Luer Lock applicatordevice

Applicator for instillation.

Vial access devicedevice

Device for withdrawal of drug product.

aprepitantdrug

Aprepitant, three single doses of aprepitant will be administered orally.