- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109312
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
October 25, 2023 updated by: Heron Therapeutics
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Woodland International Research Group, LLC
-
-
Florida
-
Sarasota, Florida, United States, 34232
- Gulfcoast Research Institute
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74104
- The Orthopaedic Center
-
-
Texas
-
Bellaire, Texas, United States, 77401
- First Surgical Hospital
-
Carrollton, Texas, United States, 75006
- Legent Orthopedic Hospital
-
San Antonio, Texas, United States, 78240
- Endeavor Clinical Trials, LLC
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- JBR Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group 1 Cohort 1
HTX-011 + multimodal analgesic (MMA) regimen
|
400 mg
Applicator for instillation
400 mg
1 g
|
Active Comparator: Treatment Group 2 Cohort 1
Bupivacaine HCl + MMA
|
400 mg
1 g
100 mg
125 mg
|
Experimental: Treatment Group 1 Cohort 2
HTX-011 + MMA
|
400 mg
Applicator for instillation
400 mg
1 g
|
Active Comparator: Treatment Group 2 Cohort 2
Bupivacaine HCl + MMA
|
400 mg
1 g
100 mg
125 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment-emergent adverse events (TEAEs).
Time Frame: Through Day 15
|
Through Day 15
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum concentration (Cmax) of bupivacaine and meloxicam
Time Frame: Through 144 hours
|
Through 144 hours
|
Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam
Time Frame: Through 144 hours
|
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
Time Frame: Through 144 hours
|
Through 144 hours
|
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam
Time Frame: Through 144 hours
|
Through 144 hours
|
Apparent terminal half-life (t½) of bupivacaine and meloxicam
Time Frame: Through 144 hours
|
Through 144 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2021
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
November 5, 2021
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Anesthetics, Local
- Acetaminophen
- Bupivacaine
- Ibuprofen
Other Study ID Numbers
- HTX-011-401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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