Trial intelligence / Profile preview

HTX-034 for Postoperative Analgesia in Bunionectomy

NCT04398329Phase 2

Key facts

Status: Completed
Start: May 2020
Primary completion: Jul 2021
Countries: 1
Sponsor: Heron Therapeutics, Inc.
Modality: Implantable Devices, Transdermal Patches, Inhalation Devices

Drugs: aprepitant/bupivacaine/meloxicam
Conditions: postoperative pain

Overview

Phase 2, randomised, double-blind trial of aprepitant/bupivacaine/meloxicam in postoperative pain (5 arms), sponsored by Heron Therapeutics, Inc. Primary endpoints: Incidence of Treatment-Emergent Adverse Events at 42 days and Area Under the Curve of Pain Scores from 0 to 72 hours. Started May 2020; status: completed.

Design

5 arms

Study design: RandomizedDouble-blind

Phase 1b: HTX-034 Low Dose
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg
Phase 1b: HTX-034 High Dose
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
Phase 2: HTX-034 Low Dose
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg
Phase 2: HTX-034 High Dose
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
Phase 1b/2: Bupivacaine HCl
Bupivacaine HCl (without epinephrine) 0.5%: 50 mg

Who it enrols

Patients undergoing elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, with ASA Physical Status I-III, excluding those with recent contralateral bunionectomy, significant cardiac history, coagulopathy, active infections, or severe organ impairment.

Endpoints

Primary

Incidence of Treatment-Emergent Adverse Events42 days
Area Under the Curve of Pain Scores from 0 to 72 hours72 hours

Secondary

Maximum Observed Plasma Concentration29 days
Time to Maximum Plasma Concentration29 days
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration29 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity22 days
Terminal Elimination Half-Life22 days
Mean Area Under the Curve of Pain Scores With Activity7 days
Total Opioid Consumption7 days
Proportion of Subjects Who Are Opioid-free15 days

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