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

• Status: Completed
• Trial end date: 2022-07-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heron Therapeutics
• Treatments: Acetaminophen; Bupivacaine; Ibuprofen

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.

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.