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

NCT06109428 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: HTX-011-401 (Cohort 2)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Analgesia

Keywords

postoperative pain; abdominoplasty; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs).

  Through Day 15

Secondary Outcomes (5)

• 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

Study Arms (2)

Treatment Group 1 Cohort 2

EXPERIMENTAL

HTX-011 + MMA regimen

Drug: HTX-011; Drug: Ibuprofen; Drug: Acetaminophen; Device: Luer lock applicator

Treatment Group 2 Cohort 2

ACTIVE COMPARATOR

Bupivacaine HCl + MMA regimen

Drug: Bupivacaine Hydrochloride; Drug: Ibuprofen; Drug: Acetaminophen

Interventions

HTX-011 DRUG

400 mg

Treatment Group 1 Cohort 2

Bupivacaine Hydrochloride DRUG

125 mg

Treatment Group 2 Cohort 2

Ibuprofen DRUG

400 mg

Treatment Group 1 Cohort 2; Treatment Group 2 Cohort 2

Acetaminophen DRUG

1 g

Treatment Group 1 Cohort 2; Treatment Group 2 Cohort 2

Luer lock applicator DEVICE

Applicator for instillation

Treatment Group 1 Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (2)

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In each cohort, subjects will be randomized in a 2:1 ratio to HTX-011 or bupivacaine HCl, respectively. All subjects will receive a scheduled postoperative non opioid multimodal analgesic (MMA) regimen.

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: October 12, 2021
• Primary Completion: March 29, 2022
• Study Completion: April 7, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

US (2)