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

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

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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