HTX-011 in Spinal Surgery

Post-Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911062
• Other study ID #: HTX-011-221
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2022
• Est. completion date: August 26, 2022

Study information

• Verified date: June 2023
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 26, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Laminectomy
• Pain, Postoperative
• Post-Operative Pain

Intervention

Drug:
• Bupivacaine HCI without epinephrine
100 mg administered via injection into the surgical site.
• 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.

Locations

Country	Name	City	State
United States	Austin Neurosurgeons	Austin	Texas
United States	First Surgical Hospital	Bellaire	Texas
United States	The Ohio State University Wexner Medical Center - University Hospital	Columbus	Ohio
United States	M3 Emerging Medical Research, LLC	Durham	North Carolina
United States	Houston Heights Hospital	Houston	Texas
United States	Lotus Clinical Research, LLC	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	South Texas Spine & Surgical Center	San Antonio	Texas
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Overlook Medical Center	Summit	New Jersey
United States	Kansas Spine and Specialty Hospital	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events		From the time the subject signs the ICF through the Day 29 Visit
Secondary	Maximum Observed Plasma Concentration (Cmax)		Baseline through 120 hours
Secondary	Time of occurrence of maximum concentration (Tmax)		Baseline through 120 hours
Secondary	Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)		Baseline through 120 hours
Secondary	Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)		Baseline through 120 hours
Secondary	Apparent terminal half-life (t½)		Baseline through 120 hours