Clinical trial NCT05109312: A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
Official title: A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Analgesia
Keywords: postoperative pain
total shoulder arthroplasty
abdominoplasty
multimodal analgesia
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In each cohort, subjects will be randomized in a 2:1 ratio to HTX-011 or bupivacaine HCl, respectively. All subjects will receive a scheduled postoperative non opioid multimodal analgesic (MMA) regimen.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs).
timeFrame: Through Day 15
Secondary outcomes:
measure: Maximum concentration (Cmax) of bupivacaine and meloxicam
timeFrame: Through 144 hours
measure: Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam
timeFrame: Through 144 hours
measure: Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam
timeFrame: Through 144 hours
measure: Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam
timeFrame: Through 144 hours
measure: Apparent terminal half-life (t½) of bupivacaine and meloxicam
timeFrame: Through 144 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Tulsa
country: United States
facility: The Orthopaedic Center
state: Oklahoma
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: Legent Orthopedic Hospital
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: