Clinical Trials Logo
  1. Home
  2. Inguinal Hernia
  3. NCT03591146

Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management

Inguinal Hernia Clinical Trial

Official title:
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

Clinical Trial 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®

Clinical Trial Description

A 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® via a single infiltrative local administration in adult subjects following inguinal hernia repair surgery. Approximately 64 evaluable subjects across 4 cohorts. Dose escalation of a single postsurgical administration of TLC590 or Naropin® will be performed. Dose escalation will be determined by review of treatment-related adverse events and all serious adverse events (AEs) by a safety monitoring committee. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03591146
Study type Interventional
Source Taiwan Liposome Company
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 31, 2018
Completion date January 14, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT04272320 - The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair N/A
Recruiting NCT03904888 - Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair N/A
Recruiting NCT03856710 - Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair N/A
Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
Completed NCT01943760 - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty Phase 4
Completed NCT01679353 - Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair N/A
Recruiting NCT01450345 - Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain Phase 3
Active, not recruiting NCT00968773 - Rebound Hernia Repair Device Mesh Trial Phase 4
Completed NCT01000116 - Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP) N/A
Completed NCT01117337 - Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair Phase 4
Terminated NCT00226161 - Chronic Pain After Inguinal Herniorrhaphy N/A
Completed NCT05837013 - Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia N/A
Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
Completed NCT01637818 - Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair N/A
Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A