Clinical trial NCT04911062: HTX-011 in Spinal Surgery
Official title: A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Operative Pain
Lumbar Laminectomy
Keywords: postoperative pain
local anesthetic
lumbar laminectomy
lumbar decompression
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Serious Adverse Events
timeFrame: From the time the subject signs the ICF through the Day 29 Visit
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Baseline through 120 hours
measure: Time of occurrence of maximum concentration (Tmax)
timeFrame: Baseline through 120 hours
measure: Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)
timeFrame: Baseline through 120 hours
measure: Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
timeFrame: Baseline through 120 hours
measure: Apparent terminal half-life (t½)
timeFrame: Baseline through 120 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Wichita
country: United States
facility: Kansas Spine and Specialty Hospital
state: Kansas
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Durham
country: United States
facility: M3 Emerging Medical Research, LLC
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - University Hospital
state: Ohio
city: Austin
country: United States
facility: Austin Neurosurgeons
state: Texas
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Houston Heights Hospital
state: Texas
city: San Antonio
country: United States
facility: South Texas Spine & Surgical Center
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: