A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery.
This is a phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery. This study includes 2 parts. An unblinded interim analysis will be performed after completion of part 1 (phase 2, approximately 115 subjects to be randomized for 2 different doses of TLC590, bupivacaine, ropivacaine, or placebo), for selecting a TLC590 dose for part 2 (phase 3, approximately 300 subjects to be randomized for TLC590, bupivacaine, or placebo).In this study, 2 doses of TLC590 24.5 mg/mL in inguinal hernia repair will be assessed in an initial phase 2 part before proceeding to a phase 3 pivotal evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
415
Part 1 - AUC 0-24 of NPRS-M
AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
Time frame: 0-24 hours
Part 2 - AUC 0-72 of NPRS-M
AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
Time frame: 0-72 hours
AUC 0-72 of NPRS-M (active comparator)
AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)
Time frame: 0-72 hours
Proportion of opioid-free subjects through 72 hours (placebo)
Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)
Time frame: 0-72 hours
Proportion of opioid-free subjects through 72 hours (active comparator)
Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)
Time frame: 0-72 hours
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Normal saline 20mL or 24mL