Status:
COMPLETED
HTX-011 in Spinal Surgery
Lead Sponsor:
Heron Therapeutics
Conditions:
Post-Operative Pain
Lumbar Laminectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04911062
Start Date
April 7 2022
End Date
August 26 2022
Last Update
June 12 2023
Active Locations (12)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
3
Kansas Spine and Specialty Hospital
Wichita, Kansas, United States, 67226
4
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101