HTX-011 in Spinal Surgery

June 5, 2023 updated by: Heron Therapeutics

A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • California
      • Pasadena, California, United States, 91105
        • Lotus Clinical Research, LLC
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Kansas Spine and Specialty Hospital
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • M3 Emerging Medical Research, LLC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center - University Hospital
    • Texas
      • Austin, Texas, United States, 78746
        • Austin Neurosurgeons
      • Bellaire, Texas, United States, 77401
        • First Surgical Hospital
      • Houston, Texas, United States, 77008
        • Houston Heights Hospital
      • San Antonio, Texas, United States, 78258
        • South Texas Spine & Surgical Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
  • Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

Exclusion Criteria:

  • Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
  • Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
  • Has functioning intrathecal drug pump or spinal cord stimulator.
  • Opioid use for most days within the last 3 months.
  • Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery.
  • Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
  • Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.
  • Has impaired balance and is at risk of falling.
  • Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
  • Has undergone 3 or more surgeries within 12 months.
  • Has a known history of glucose-6-phosphate dehydrogenase deficiency.
  • Has History of liver cirrhosis, having an aspartate aminotransferase >3 × the upper limit of normal (ULN), or having an alanine aminotransferase >3 × ULN.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Bupivacaine HCl
Bupivacaine HCl without epinephrine, via injection into the surgical site.
Drug: Bupivacaine HCI without epinephrine
100 mg administered via injection into the surgical site.
Experimental: Cohort 2: HTX-011
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.
Experimental: Cohort 3: HTX-011
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Serious Adverse Events
Time Frame: From the time the subject signs the ICF through the Day 29 Visit
From the time the subject signs the ICF through the Day 29 Visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Baseline through 120 hours
Baseline through 120 hours
Time of occurrence of maximum concentration (Tmax)
Time Frame: Baseline through 120 hours
Baseline through 120 hours
Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)
Time Frame: Baseline through 120 hours
Baseline through 120 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Time Frame: Baseline through 120 hours
Baseline through 120 hours
Apparent terminal half-life (t½)
Time Frame: Baseline through 120 hours
Baseline through 120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heron Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTX-011-221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Laminectomy

Clinical Trials on Luer Lock Applicator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe