Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Postsurgical Pain Management Clinical Trial

Official title:

A Phase 2/3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05161637
• Other study ID #: TLC590A2003
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2025
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Taiwan Liposome Company
• Contact: Grace Tsao
• Phone: +886-2-26557377
• Email: grace[@]tlcbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 415
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female at least 18 years old

• BMI 18-39 kg/m2

• Scheduled to undergo a primary, unilateral Lichtenstein inguinal hernia repair with mesh

• ASA Physical Status Classification of 1, 2 or 3

Exclusion Criteria:

• Clinically significant abnormal clinical laboratory test value

• Clinically significant 12-lead ECG

• History of orthostatic hypotension or syncope

• History of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition

• History of seizure or currently taking anticonvulsants

• History of hypersensitivity to bupivacaine/ropivacaine, any other amide-type local anesthetic, propofol, oxycodone or morphine (or other opioids)

• History of severe or refractory post-operative nausea or vomiting (PONV)

• Abnormalities of laboratory parameters: HbA1c, platelet, hemoglobin, WBC, serun bilirubin/alanine aminotransferase/aspartate aminotrasferase, serum creatinine, PTT/INR

• Concurrent acute, or chronic painful restrictive/physical condition

• Received opioid therapy for longer than 4 days per week

• Prohibited medication: aspirin and other anti-platelet medication, anticoagulants, class III antiarrhythmic drugs, strong CYP1A2 inhibitors,systemic corticosteroids, NSAID, opioid, bupivacaine or ropivacaine, any investigational product

• History of drug abuse or alcohol abuse

• Positive results on the urine drug screen or alcohol breath test

• History of HIV; active HBV or HCV

• An inguinal hernia repair in the last 3 months or has undergone 3 or more surgeries within 12 months

• Malignancy in the last 2 years

• Documented sleep apnea or on home continuous positive airway pressure treatment (CPAP)

• Personal or family history of malignant hyperthermia.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain Management

Intervention

Drug:
• TLC590
TLC590 490mg or 588mg
• Bupivacain
Bupivacaine 75mg
• Ropivacaine
Ropivacaine 150mg
• Normal saline
Normal saline 20mL or 24mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 - AUC 0-24 of NPRS-M	AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo	0-24 hours
Primary	Part 2 - AUC 0-72 of NPRS-M	AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo	0-72 hours
Secondary	AUC 0-72 of NPRS-M (active comparator)	AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)	0-72 hours
Secondary	Proportion of opioid-free subjects through 72 hours (placebo)	Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)	0-72 hours
Secondary	Proportion of opioid-free subjects through 72 hours (active comparator)	Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)	0-72 hours