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

NCT05109312 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-10-26

No results posted yet for this study

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.

Conditions

  • Analgesia

Interventions

DRUG

Bupivacaine Hydrochloride

100 mg

DRUG

Bupivacaine Hydrochloride

125 mg

DRUG

HTX-011

400 mg

DEVICE

Luer lock applicator

Applicator for instillation

DRUG

Ibuprofen

400 mg

DRUG

Acetaminophen

1 g

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109312 on ClinicalTrials.gov