CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 78 enrolled / 78 target
Drug / intervention
HTX-034 low dose +3 moredrug
Likely dose
HTX-034 low dose 21.7 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/NCT04398329
NCT04398329Phase 1CompletedMonitor (1.1/mo)Completion was 59mo ago
CompareCT.gov

A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation

Heron Therapeutics·interventional·Posted May 21, 2020·Updated Jun 9, 2026

In Brief

A Phase 1 clinical trial evaluating HTX-034 low dose, HTX-034 high dose, and 2 other interventions for Bunions and Postoperative Pain. Completed, enrolled 78 participants across 4 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBunions, Postoperative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedMay 21, 2020
Enrollment StartMay 8, 2020
Primary CompletionJul 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.1 years ago

Arms & Interventions

Phase 1b: HTX-034 Low Doseexperimental

Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 low doseDevice: Luer lock applicator
Phase 1b: HTX-034 High Doseexperimental

Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 high doseDevice: Luer lock applicator
Phase 2: HTX-034 Low Doseexperimental

Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 low doseDevice: Luer lock applicator
Phase 2: HTX-034 High Doseexperimental

Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 high doseDevice: Luer lock applicator
Phase 1b/2: Bupivacaine HClactive_comparator

Bupivacaine HCl (without epinephrine) 0.5%: 50 mg

Drug: Bupivacaine HCl

Interventions

HTX-034 low dosedrug

HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg

HTX-034 high dosedrug

HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg

Luer lock applicatordevice

Applicator for instillation

Bupivacaine HCldrug

Bupivacaine HCl 50 mg