Phase 2/3 Study of TLC590 for Postsurgical Pain Management

NCT ID: NCT05161637

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2025-12-31

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.

Conditions

Postsurgical Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TLC590 490mg

TLC590 490mg (20mL)

Group Type: EXPERIMENTAL

TLC590

Intervention Type: DRUG

TLC590 490mg or 588mg

TLC590 588mg

TLC590 588mg (24mL)

Group Type: EXPERIMENTAL

TLC590

Intervention Type: DRUG

TLC590 490mg or 588mg

Bupivacaine 75mg

Bupivacaine HCl 75mg (30mL)

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

Bupivacaine 75mg

Ropivacaine

Ropivacaine HCl 150mg (30mL) (Part 1)

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Ropivacaine 150mg

Normal saline

Normal Saline 0.9% (20mL or 24mL)

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline 20mL or 24mL

Interventions

TLC590

TLC590 490mg or 588mg

Intervention Type: DRUG

Bupivacain

Bupivacaine 75mg

Intervention Type: DRUG

Ropivacaine

Ropivacaine 150mg

Intervention Type: DRUG

Normal saline

Normal saline 20mL or 24mL

Intervention Type: DRUG

Other Intervention Names

intestigational drug; active comparator; active comparator; placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Liposome Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry Tai, PhD

Role: STUDY_DIRECTOR

Taiwan Liposome Company

Central Contacts

Grace Tsao

Role: CONTACT

grace@tlcbio.com

+886-2-26557377

Other Identifiers

TLC590A2003

Identifier Type: -

Identifier Source: org_study_id