At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
TLC590 +1 moredrug
Likely dose
Naropin 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Randomized, Double-blind, Comparator-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair
In Brief
A Phase 2 clinical trial evaluating TLC590 and Naropin for Inguinal Hernia. Completed, enrolled 65 participants across 1 site.
Detailed Summary
Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInguinal Hernia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartJul 2018
Primary CompletionJan 2019
Study CompletionJan 2019
TodayJul 2026
First PostedJul 19, 2018
Enrollment StartJul 31, 2018
Primary CompletionJan 5, 2019
Study CompletionJan 14, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago
Interventions
TLC590drug
TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
Naropindrug
Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL