A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
Phase 4
Active, not recruiting
- Conditions
- Analgesia
- Interventions
- Device: Luer lock applicator
- Registration Number
- NCT05109312
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group 1 Cohort 2 Luer lock applicator HTX-011 + MMA Treatment Group 1 Cohort 1 HTX-011 HTX-011 + multimodal analgesic (MMA) regimen Treatment Group 1 Cohort 1 Luer lock applicator HTX-011 + multimodal analgesic (MMA) regimen Treatment Group 1 Cohort 2 HTX-011 HTX-011 + MMA Treatment Group 1 Cohort 1 Ibuprofen HTX-011 + multimodal analgesic (MMA) regimen Treatment Group 1 Cohort 1 Acetaminophen HTX-011 + multimodal analgesic (MMA) regimen Treatment Group 2 Cohort 1 Bupivacaine Hydrochloride Bupivacaine HCl + MMA Treatment Group 2 Cohort 1 Ibuprofen Bupivacaine HCl + MMA Treatment Group 2 Cohort 1 Acetaminophen Bupivacaine HCl + MMA Treatment Group 1 Cohort 2 Ibuprofen HTX-011 + MMA Treatment Group 2 Cohort 2 Bupivacaine Hydrochloride Bupivacaine HCl + MMA Treatment Group 1 Cohort 2 Acetaminophen HTX-011 + MMA Treatment Group 2 Cohort 2 Ibuprofen Bupivacaine HCl + MMA Treatment Group 2 Cohort 2 Acetaminophen Bupivacaine HCl + MMA
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs). Through Day 15
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Endeavor Clinical Trials, LLC
🇺🇸San Antonio, Texas, United States
First Surgical Hospital
🇺🇸Bellaire, Texas, United States
Legent Orthopedic Hospital
🇺🇸Carrollton, Texas, United States
Gulfcoast Research Institute
🇺🇸Sarasota, Florida, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
The Orthopaedic Center
🇺🇸Tulsa, Oklahoma, United States