Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Taiwan Liposome Company (TLC)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Postsurgical Pain Management

Treatments: Drug: Ropivacaine; Drug: Normal saline; Drug: TLC590; Drug: Bupivacain

Study type: Interventional

Funder types: Industry

Identifiers

NCT05161637

TLC590A2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 415 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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415 participants in 5 patient groups, including a placebo group

TLC590 490mg

Experimental group

Description:

TLC590 490mg (20mL)

Treatment:

Drug: TLC590

TLC590 588mg

Experimental group

Description:

TLC590 588mg (24mL)

Treatment:

Drug: TLC590

Bupivacaine 75mg

Active Comparator group

Description:

Bupivacaine HCl 75mg (30mL)

Treatment:

Drug: Bupivacain

Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Normal saline

Placebo Comparator group

Description:

Normal Saline 0.9% (20mL or 24mL)

Treatment:

Drug: Normal saline