This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
TLC590 (Ropivacaine Extended-Release Injectable Suspension)
Bupivacaine Liposome Injectable Suspension
Normal Saline 0.9%
Clinical Pharmacology of Miami
Miami, Florida, United States
NOT_YET_RECRUITINGFirst Surgical Hospital
Bellaire, Texas, United States
RECRUITINGMemorial Hermann Village
Houston, Texas, United States
RECRUITINGMean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Saline Placebo.
Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
Time frame: 72 hours
Proportion of subjects who are opioid-free for TLC590 compared with Saline Placebo.
Time frame: 72 hours
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Bupivacaine Liposome.
Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Saline Placebo
Time frame: 72 hours
Proportion of subjects who are opioid-free for TLC590 compared with Bupivacaine Liposome.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Bupivacaine Liposome.
Time frame: 72 hours
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Endeavor Clinical Trials
San Antonio, Texas, United States
NOT_YET_RECRUITING