HTX-011 in Spinal Surgery

Phase 2

Completed

Interventions: Drug: Bupivacaine HCI without epinephrine
Drug: HTX-011
Device: Luer Lock Applicator

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

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Cohort 1: Bupivacaine HCl	Bupivacaine HCI without epinephrine	Bupivacaine HCl without epinephrine, via injection into the surgical site.
Cohort 3: HTX-011	HTX-011	HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Cohort 3: HTX-011	Luer Lock Applicator	HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Cohort 2: HTX-011	HTX-011	HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Cohort 2: HTX-011	Luer Lock Applicator	HTX-011 (bupivacaine/meloxicam) via application into the surgical site.

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events	From the time the subject signs the ICF through the Day 29 Visit

Secondary Outcome Measures

Name	Time	Method
Time of occurrence of maximum concentration (Tmax)	Baseline through 120 hours
Maximum Observed Plasma Concentration (Cmax)	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

Locations (12): South Texas Spine & Surgical Center
🇺🇸
San Antonio, Texas, United States
M3 Emerging Medical Research, LLC
🇺🇸
Durham, North Carolina, United States
Austin Neurosurgeons
🇺🇸
Austin, Texas, United States
JBR Clinical Research
🇺🇸
Salt Lake City, Utah, United States
First Surgical Hospital
🇺🇸
Bellaire, Texas, United States
Houston Heights Hospital
🇺🇸
Houston, Texas, United States
Spine Institute of Louisiana
🇺🇸
Shreveport, Louisiana, United States
The Ohio State University Wexner Medical Center - University Hospital
🇺🇸
Columbus, Ohio, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Lotus Clinical Research, LLC
🇺🇸
Pasadena, California, United States
Kansas Spine and Specialty Hospital
🇺🇸
Wichita, Kansas, United States
Overlook Medical Center
🇺🇸
Summit, New Jersey, United States