This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
418
HTX 011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation
Bupivacaine HCl without epinephrine, 75 mg by injection
Saline placebo by instillation
Eliza Coffee Memorial Hospital
Florence, Alabama, United States
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting up from a resting position.
Time frame: 72 hours
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl.
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting up from a resting position.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.
Time frame: 72 hours
Percetange of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.
Time frame: 72 hours
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Applicator for instillation
Device for withdrawal of drug product
Shoals Medical Trials, Inc.
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Trovare Clinical Research, Inc.
Bakersfield, California, United States
Alliance Research Centers
Laguna Hills, California, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
HD Research Corp
Riverside, California, United States
American Institute of Research
Whittier, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
...and 14 more locations