This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
100 mg administered via injection into the surgical site.
HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.
Applicator for instillation.
Arizona Research Center
Phoenix, Arizona, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
Kansas Spine and Specialty Hospital
Wichita, Kansas, United States
Incidence of Serious Adverse Events
Time frame: From the time the subject signs the ICF through the Day 29 Visit
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline through 120 hours
Time of occurrence of maximum concentration (Tmax)
Time frame: Baseline through 120 hours
Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)
Time frame: Baseline through 120 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Time frame: Baseline through 120 hours
Apparent terminal half-life (t½)
Time frame: Baseline through 120 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 2 more locations