Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Phase 2

Not yet recruiting

• Conditions: Postsurgical Pain Management
• Interventions: Drug: Normal saline; Drug: TLC590; Drug: Bupivacain; Drug: Ropivacaine

• Registration Number: NCT05161637
• Lead Sponsor: Taiwan Liposome Company

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Study Start: 2025-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 415

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Normal Saline 0.9% (20mL or 24mL)
TLC590 588mg	TLC590	TLC590 588mg (24mL)
Bupivacaine 75mg	Bupivacain	Bupivacaine HCl 75mg (30mL)
TLC590 490mg	TLC590	TLC590 490mg (20mL)
Ropivacaine	Ropivacaine	Ropivacaine HCl 150mg (30mL) (Part 1)

Primary Outcome Measures

Name	Time	Method
Part 1 - AUC 0-24 of NPRS-M	0-24 hours	AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo
Part 2 - AUC 0-72 of NPRS-M	0-72 hours	AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo

Secondary Outcome Measures

Name	Time	Method
AUC 0-72 of NPRS-M (active comparator)	0-72 hours	AUC 0-72 of NPRS-M (TLC590 vs Bupivacaine)
Proportion of opioid-free subjects through 72 hours (active comparator)	0-72 hours	Proportion of opioid-free subjects through 72 hours (TLC590 vs. Bupivacaine)
Proportion of opioid-free subjects through 72 hours (placebo)	0-72 hours	Proportion of opioid-free subjects through 72 hours (TLC590 vs. Placebo)