A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE
NCT ID: NCT06109428
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2021-10-12
2022-04-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Group 1 Cohort 2
HTX-011 + MMA regimen
HTX-011
400 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Luer lock applicator
Applicator for instillation
Treatment Group 2 Cohort 2
Bupivacaine HCl + MMA regimen
Bupivacaine Hydrochloride
125 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HTX-011
400 mg
Bupivacaine Hydrochloride
125 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Luer lock applicator
Applicator for instillation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Is scheduled to undergo abdominoplasty.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heron Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
First Surgical Hospital
Bellaire, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HTX-011-401 (Cohort 2)
Identifier Type: -
Identifier Source: org_study_id