Phase 2/3 Study of TLC590 for Postsurgical Pain Management

NCT05161637 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: TLC590A2003
• Study Type: interventional
• Target: 415
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postsurgical Pain Management

Outcome Measures

Primary Outcomes (2)

• Part 1 - AUC 0-24 of NPRS-M

  AUC 0-24 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo

  0-24 hours

• Part 2 - AUC 0-72 of NPRS-M

  AUC 0-72 of NPRS-M, evaluated comparing each dose of TLC590 with Placebo

  0-72 hours

Secondary Outcomes (3)

• AUC 0-72 of NPRS-M (active comparator)

  0-72 hours

• Proportion of opioid-free subjects through 72 hours (placebo)

  0-72 hours

• Proportion of opioid-free subjects through 72 hours (active comparator)

  0-72 hours

Study Arms (5)

TLC590 490mg

EXPERIMENTAL

TLC590 490mg (20mL)

Drug: TLC590

TLC590 588mg

EXPERIMENTAL

TLC590 588mg (24mL)

Drug: TLC590

Bupivacaine 75mg

ACTIVE COMPARATOR

Bupivacaine HCl 75mg (30mL)

Drug: Bupivacain

Ropivacaine

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Normal saline

PLACEBO COMPARATOR

Normal Saline 0.9% (20mL or 24mL)

Drug: Normal saline

Interventions

TLC590 DRUG

TLC590 490mg or 588mg

Also known as: intestigational drug

TLC590 490mg; TLC590 588mg

Bupivacain DRUG

Bupivacaine 75mg

Also known as: active comparator

Bupivacaine 75mg

Ropivacaine DRUG

Ropivacaine 150mg

Also known as: active comparator

Ropivacaine

Normal saline DRUG

Normal saline 20mL or 24mL

Also known as: placebo

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Liposome Company: lead

MeSH Terms

Interventions

Bupivacaine; Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Terry Tai, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Central Study Contacts

Grace Tsao

CONTACT

+886-2-26557377; grace@tlcbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share