Phase 2/3 Study of TLC590 for Postsurgical Pain Management

Launched by TAIWAN LIPOSOME COMPANY · Dec 3, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called TLC590 to help manage pain after surgery, specifically after inguinal hernia repair surgery. The goal is to find out how safe and effective this treatment is for adults who have just had this type of surgery. The study will be organized in two parts and will compare TLC590 to a placebo (a treatment that has no active ingredients) to see how well it works.

To participate in this trial, you must be at least 18 years old and scheduled for a specific type of hernia surgery. You should have a body mass index (BMI) between 18 and 39, and your overall health should be classified as stable (levels 1, 2, or 3 on a scale used by doctors). However, certain health conditions or medications may prevent you from joining. If you decide to participate, you will receive treatment and be monitored by healthcare professionals to ensure your safety and gather information about your recovery. This trial is not currently recruiting participants, but it aims to provide valuable information for future pain management after surgery.

Gender

ALL

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.