Clinical trial NCT05161637: Phase 2/3 Study of TLC590 for Postsurgical Pain Management
Official title: A Phase 2/3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Postsurgical Pain Management
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Part 1 - AUC 0-24 of NPRS-M
timeFrame: 0-24 hours
measure: Part 2 - AUC 0-72 of NPRS-M
timeFrame: 0-72 hours
Secondary outcomes:
measure: AUC 0-72 of NPRS-M (active comparator)
timeFrame: 0-72 hours
measure: Proportion of opioid-free subjects through 72 hours (placebo)
timeFrame: 0-72 hours
measure: Proportion of opioid-free subjects through 72 hours (active comparator)
timeFrame: 0-72 hours
Other outcomes:
Locations:
Study officials:
affiliation: Taiwan Liposome Company
name: Terry Tai, PhD
role: STUDY_DIRECTOR
References: