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

NCT06109415 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-31

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 Total Shoulder Arthroplasty (TSA) (Cohort 1).

Conditions

  • Postoperative Pain
  • Total Shoulder Arthroplasty
  • Multimodal Analgesia

Interventions

DRUG

HTX-011

400 mg

DRUG

Bupivacaine Hydrochloride

100 mg

DRUG

Ibuprofen

400 mg

DRUG

Acetaminophen

1 g

DEVICE

Luer lock applicator

Applicator for instillation

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
2021-10-20
Primary Completion
2022-07-18
Completion
2022-07-29
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 NCT06109415 on ClinicalTrials.gov