HTX-011 in Spinal Surgery

Completed · Phase 2

Conditions studied: Post-Operative Pain, Lumbar Laminectomy

In brief

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

Key facts

Study ID

NCT04911062

Run by

Heron Therapeutics

People needed

32

Starts

2022-04-07

Expected to finish

2022-08-26

Last updated by the study team

2023-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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