A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE

A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Abdominoplasty (Cohort 2)

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing abdominoplasty (Cohort 2).

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Ibuprofen; Device: Luer lock applicator; Drug: HTX-011; Drug: Acetaminophen; Drug: Bupivacaine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Bellaire, Texas, United States, 77401
      • First Surgical Hospital
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
• Is scheduled to undergo abdominoplasty.

Exclusion Criteria:

• Is undergoing a revision surgery.
• Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
• History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
• Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
• Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
• Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
• Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
• Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
• Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
• Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
• Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
• Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy).
• Has a body mass index (BMI) >40 kg/m2.
• Had undergone prior abdominoplasty or major abdominal wall surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 1 Cohort 2; HTX-011 + MMA regimen	Drug: Ibuprofen; 400 mg; Device: Luer lock applicator; Applicator for instillation; Drug: HTX-011; 400 mg; Drug: Acetaminophen; 1 g
Active Comparator: Treatment Group 2 Cohort 2; Bupivacaine HCl + MMA regimen	Drug: Ibuprofen; 400 mg; Drug: Acetaminophen; 1 g; Drug: Bupivacaine Hydrochloride; 125 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs).	Through Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax) of bupivacaine and meloxicam	Through 144 hours
Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam	Through 144 hours
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam	Through 144 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam	Through 144 hours
Apparent terminal half-life (t½) of bupivacaine and meloxicam	Through 144 hours

Collaborators and Investigators

• Sponsor: Heron Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: postoperative pain; multimodal analgesia; abdominoplasty
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Anesthetics, Local; Acetaminophen; Bupivacaine; Ibuprofen
• Other Study ID Numbers: HTX-011-401 (Cohort 2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes