A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.

H

Heron Therapeutics

Status and phase

Active, not recruiting
Phase 4

Conditions

Analgesia

Treatments

Drug: Acetaminophen
Drug: HTX-011
Drug: Bupivacaine Hydrochloride
Device: Luer lock applicator
Drug: Ibuprofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT05109312
HTX-011-401

Details and patient eligibility

About

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Is scheduled to undergo a unilateral Total Shoulder Arthroplasty (TSA) or 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 4 patient groups

Treatment Group 1 Cohort 1
Experimental group
Description:
HTX-011 + multimodal analgesic (MMA) regimen
Treatment:
Drug: Ibuprofen
Device: Luer lock applicator
Drug: HTX-011
Drug: Acetaminophen
Treatment Group 2 Cohort 1
Active Comparator group
Description:
Bupivacaine HCl + MMA
Treatment:
Drug: Ibuprofen
Drug: Bupivacaine Hydrochloride
Drug: Acetaminophen
Treatment Group 1 Cohort 2
Experimental group
Description:
HTX-011 + MMA
Treatment:
Drug: Ibuprofen
Device: Luer lock applicator
Drug: HTX-011
Drug: Acetaminophen
Treatment Group 2 Cohort 2
Active Comparator group
Description:
Bupivacaine HCl + MMA
Treatment:
Drug: Ibuprofen
Drug: Bupivacaine Hydrochloride
Drug: Acetaminophen

Trial contacts and locations

7

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Central trial contact

Sophie Visonneau

Data sourced from clinicaltrials.gov

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