HTX-011 in Spinal Surgery

Heron Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lumbar Laminectomy; Post-Operative Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04911062

HTX-011-221

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Cohort 1: Bupivacaine HCl

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine HCI without epinephrine

Cohort 2: HTX-011

Experimental group

Description:

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

Treatment:

Drug: HTX-011

Device: Luer Lock Applicator

Cohort 3: HTX-011

Experimental group

Description:

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

Treatment:

Drug: HTX-011

Device: Luer Lock Applicator