A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.
NCT ID: NCT06109415
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
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2021-10-20
2022-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Group 1 Cohort 1
HTX-011 + multimodal analgesic (MMA) regimen
HTX-011
400 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Luer lock applicator
Applicator for instillation
Treatment Group 2 Cohort 1
Bupivacaine HCl + MMA regimen
Bupivacaine Hydrochloride
100 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Interventions
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HTX-011
400 mg
Bupivacaine Hydrochloride
100 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Luer lock applicator
Applicator for instillation
Eligibility Criteria
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Inclusion Criteria
* Is scheduled to undergo a unilateral Total Shoulder Arthroplasty.
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.
18 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Center for Orthopaedic Reconstruction and Excellence
Jenks, Oklahoma, United States
First Surgical Hospital
Bellaire, Texas, United States
Legent Orthopedic Hospital
Carrollton, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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HTX-011-401 (Cohort 1)
Identifier Type: -
Identifier Source: org_study_id