HTX-011 in Spinal Surgery

NCT04911062 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: HTX-011-221
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Post-Operative Pain; Lumbar Laminectomy

Keywords

postoperative pain; local anesthetic; lumbar laminectomy; lumbar decompression

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events

  From the time the subject signs the ICF through the Day 29 Visit

Secondary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax)

  Baseline through 120 hours

• Time of occurrence of maximum concentration (Tmax)

  Baseline through 120 hours

• Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)

  Baseline through 120 hours

• Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)

  Baseline through 120 hours

• Apparent terminal half-life (t½)

  Baseline through 120 hours

Study Arms (3)

Cohort 1: Bupivacaine HCl

EXPERIMENTAL

Bupivacaine HCl without epinephrine, via injection into the surgical site.

Drug: Bupivacaine HCI without epinephrine

Cohort 2: HTX-011

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam) via application into the surgical site.

Drug: HTX-011; Device: Luer Lock Applicator

Cohort 3: HTX-011

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam) via application into the surgical site.

Drug: HTX-011; Device: Luer Lock Applicator

Interventions

Bupivacaine HCI without epinephrine DRUG

100 mg administered via injection into the surgical site.

Cohort 1: Bupivacaine HCl

HTX-011 DRUG

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

Cohort 2: HTX-011; Cohort 3: HTX-011

Luer Lock Applicator DEVICE

Applicator for instillation.

Cohort 2: HTX-011; Cohort 3: HTX-011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (12)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Kansas Spine and Specialty Hospital

Wichita, Kansas, 67226, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

M3 Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

The Ohio State University Wexner Medical Center - University Hospital

Columbus, Ohio, 43210, United States

Location

Austin Neurosurgeons

Austin, Texas, 78746, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Houston Heights Hospital

Houston, Texas, 77008, United States

Location

South Texas Spine & Surgical Center

San Antonio, Texas, 78258, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Optional Part B will be randomized, blinded, active-controlled.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: April 7, 2022
• Primary Completion: July 29, 2022
• Study Completion: August 26, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

US (12)