HTX-011 in Spinal Surgery

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

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

Conditions
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Post-Operative Pain, Lumbar Laminectomy

Intervention / Treatment
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* Drug: Bupivacaine HCI without epinephrine
* Drug: HTX-011
* Device: Luer Lock Applicator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, local anesthetic, lumbar laminectomy, lumbar decompression