Status:
COMPLETED
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE
Lead Sponsor:
Heron Therapeutics
Conditions:
Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Is scheduled to undergo abdominoplasty.
Exclusion
- 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.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06109428
Start Date
October 12 2021
End Date
April 7 2022
Last Update
October 31 2023
Active Locations (2)
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1
First Surgical Hospital
Bellaire, Texas, United States, 77401
2
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78229