A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.

Analgesia Clinical Trial

Official title:

A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05109312
• Other study ID #: HTX-011-401
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 12, 2021
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Bupivacaine Hydrochloride
100 mg
• Bupivacaine Hydrochloride
125 mg
• HTX-011
400 mg

Device:
• Luer lock applicator
Applicator for instillation

Drug:
• Ibuprofen
400 mg
• Acetaminophen
1 g

Locations

Country	Name	City	State
United States	First Surgical Hospital	Bellaire	Texas
United States	Legent Orthopedic Hospital	Carrollton	Texas
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials, LLC	San Antonio	Texas
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	The Orthopaedic Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs).		Through Day 15
Secondary	Maximum concentration (Cmax) of bupivacaine and meloxicam		Through 144 hours
Secondary	Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam		Through 144 hours
Secondary	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
Secondary	Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam		Through 144 hours
Secondary	Apparent terminal half-life (t½) of bupivacaine and meloxicam		Through 144 hours