Phase 2/3 Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery. In this study, 2 doses of a concentration 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Liposome Company

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

• History or positive HIV, 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)