A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE
Phase 4
Completed
- Conditions
- Analgesia
- Interventions
- Device: Luer lock applicator
- Registration Number
- NCT06109428
- Lead Sponsor
- Heron Therapeutics
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group 1 Cohort 2 HTX-011 HTX-011 + MMA regimen Treatment Group 2 Cohort 2 Bupivacaine Hydrochloride Bupivacaine HCl + MMA regimen Treatment Group 1 Cohort 2 Luer lock applicator HTX-011 + MMA regimen Treatment Group 2 Cohort 2 Ibuprofen Bupivacaine HCl + MMA regimen Treatment Group 2 Cohort 2 Acetaminophen Bupivacaine HCl + MMA regimen Treatment Group 1 Cohort 2 Ibuprofen HTX-011 + MMA regimen Treatment Group 1 Cohort 2 Acetaminophen HTX-011 + MMA regimen
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs). Through Day 15
- Secondary Outcome Measures
Name Time Method 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 Apparent terminal half-life (t½) 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 Maximum concentration (Cmax) of bupivacaine and meloxicam Through 144 hours
Trial Locations
- Locations (2)
First Surgical Hospital
🇺🇸Bellaire, Texas, United States
Endeavor Clinical Trials, LLC
🇺🇸San Antonio, Texas, United States
First Surgical Hospital🇺🇸Bellaire, Texas, United States