A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

NCT03838133 | Completed Phase 2 FDA Drug

• 1 other identifier: TLC590A1002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• AUC of numerical pain rating scale

  AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery

  0-24 hours, 0-72 hours

Secondary Outcomes (12)

• PK Cmax

  0-168 hours

• PK Tmax

  0-168 hours

• PK t½

  0-168 hours

• PK AUC

  0-24, 0-48 , 0-72, 0-96 hours

• Number of treatment emergent adverse event (TEAE)

  Screening through Day 43

Study Arms (6)

TLC590 dose 1 (152 mg)

EXPERIMENTAL

TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.

Drug: TLC590

TLC590 dose 2 (190 mg)

EXPERIMENTAL

TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.

Drug: TLC590

TLC590 dose 3 (228 mg)

EXPERIMENTAL

TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.

Drug: TLC590

Naropin®

ACTIVE COMPARATOR

Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL)

Drug: Naropin®

Placebo

PLACEBO COMPARATOR

Normal Saline (0.9% sodium chloride, 10 mL)

Drug: Normal Saline

Bupivacaine

ACTIVE COMPARATOR

Bupivacaine HCl 50 mg (0.5%, 10 mL)

Drug: Bupivacaine

Interventions

TLC590 DRUG

TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients

Also known as: TLC590 (Ropivacaine Liposome Injectable Suspension)

TLC590 dose 1 (152 mg); TLC590 dose 2 (190 mg); TLC590 dose 3 (228 mg)

Naropin® DRUG

Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)

Also known as: Naropin, 0.5% Injectable Solution

Naropin®

Normal Saline DRUG

Normal Saline (0.9% sodium chloride, 10ml)

Also known as: Saline

Placebo

Bupivacaine DRUG

Bupivacaine 50 mg (0.5%, 10 mL)

Bupivacaine

Eligibility Criteria

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

You may qualify if:

• Able and willing to provide a written informed consent.
• Male or female between 18 and 65 years of age.
• Body mass index ≤ 35 kg/m2.
• Mild to moderate hallux valgus deformity.
• Scheduled to undergo a primary, unilateral first metatarsal bunionectomy repair under local anesthesia.
• American Society of Anesthesiology Physical Status Classification of 1 or 2 at screening.
• Female subjects are eligible only if all of the following apply:
• Not pregnant;
• Not lactating;
• Not planning to become pregnant during the study;
• Commits to the use of an acceptable form of birth control for the duration of the study and for 42 days from administration of study drug.
• Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control, for the duration of the study until at least 1 week after the administration of study medication.

You may not qualify if:

• Clinically significant abnormal clinical laboratory test value.
• Evidence of a clinically significant 12-lead ECG abnormality.
• History or evidence of orthostatic hypotension, syncope or other syncopal attacks.
• History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
• A history of seizure disorder or currently taking anticonvulsants.
• History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, lidocaine, midazolam, acetaminophen, naproxen, morphine or oxycodone (or other opioids).
• Concurrent painful physical condition that may confound post-operative pain assessments.
• Persistent or recurrent nausea and/or vomiting due to other etiologies.
• History of severe or refractory post-operative nausea or vomiting (PONV) deemed clinically significant.
• History of alcohol abuse or prescription/illicit drug abuse within 2 years.
• Current evidence of alcohol abuse within 6 months.
• Received opioid therapy for longer than 4 days per week within 2 months or opioid use within 2 weeks.
• Use of concurrent therapy that could interfere with the evaluation of efficacy or safety.
• Unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the study surgical procedure, within 5 half-lives of the specific prior medication.
• Use of any of the following medications within 5 half-lives or as specified prior to the study surgical procedure:

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (5)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122-1020, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

JBR clinical research

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Hallux Valgus

Interventions

Ropivacaine; Saline Solution; Sodium Chloride; Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Carl Brown, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 12, 2019
• Study Start: March 5, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)