MedTrace Logo

HTX-011 in Spinal Surgery

NCT04911062 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-06-12

No results posted yet for this study

Summary

This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.

Conditions

  • Post-Operative Pain
  • Lumbar Laminectomy

Interventions

DRUG

Bupivacaine HCI without epinephrine

100 mg administered via injection into the surgical site.

DRUG

HTX-011

HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.

DEVICE

Luer Lock Applicator

Applicator for instillation.

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2022-07-29
Completion
2022-08-26
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04911062 on ClinicalTrials.gov