A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures
1 other identifier
interventional
90
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2021
Typical duration for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2021
CompletedStudy Start
First participant enrolled
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedOctober 26, 2023
October 1, 2023
2.6 years
October 1, 2021
October 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs).
Through Day 15
Secondary Outcomes (5)
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
Study Arms (4)
Treatment Group 1 Cohort 1
EXPERIMENTALHTX-011 + multimodal analgesic (MMA) regimen
Treatment Group 2 Cohort 1
ACTIVE COMPARATORBupivacaine HCl + MMA
Treatment Group 1 Cohort 2
EXPERIMENTALHTX-011 + MMA
Treatment Group 2 Cohort 2
ACTIVE COMPARATORBupivacaine HCl + MMA
Interventions
Applicator for instillation
400 mg
1 g
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
Gulfcoast Research Institute
Sarasota, Florida, 34232, United States
The Orthopaedic Center
Tulsa, Oklahoma, 74104, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Legent Orthopedic Hospital
Carrollton, Texas, 75006, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2021
First Posted
November 5, 2021
Study Start
October 12, 2021
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
October 26, 2023
Record last verified: 2023-10