Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain

Osteoarthritis of the Knee Clinical Trial

— EXCELLENCE  

Official title:

A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123561
• Other study ID #: TLC599A3005
• Status: Completed
• Phase: Phase 3
• Start date: November 26, 2019
• Est. completion date: February 3, 2022

Study information

• Verified date: August 2022
• Source: Taiwan Liposome Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.

Description:

This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Male or female =40 years of age. BMI = 40 kg/m2. Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score =4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements. Exclusion Criteria: Recent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for =5 years Known allergy or hypersensitivity to the study drugs or their components

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• TLC599
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
• DSP
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.

Other:
• Normal Saline
0.9% normal saline

Locations

Country	Name	City	State
Australia	Genesis Research Services	Broadmeadow	New South Wales
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	Northern Sydney Local Health District	Saint Leonards	New South Wales
Australia	Austrials	Taringa	Queensland
Australia	Colin Bayliss Research and Teaching Unit	Victoria Park	Western Australia
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Affinity Orthopedic Specialists Llc	Birmingham	Alabama
United States	Cahaba Research, Inc	Birmingham	Alabama
United States	Charlottesville Medical Research Center Llc	Charlottesville	Virginia
United States	Chicago Clinical Research Institute, Inc.	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	University Clinical Research-Deland, Llc Dba Accel Clinical Research	DeLand	Florida
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Medisphere Medical Research Center Llc	Evansville	Indiana
United States	Lillestol Research Llc	Fargo	North Dakota
United States	Healthcare Research Network Ii, Llc	Flossmoor	Illinois
United States	Drug Trials America	Hartsdale	New York
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Charter Research, Llc	Lady Lake	Florida
United States	Drug Studies America	Marietta	Georgia
United States	Georgia Institute For Clinical Research Llc	Marietta	Georgia
United States	Well Pharma Medical Research Corp	Miami	Florida
United States	Delricht Research	New Orleans	Louisiana
United States	Better Health Clinical Research Inc	Newnan	Georgia
United States	Lowcountry Orthopedics C/O Coastal Carolina research center	North Charleston	South Carolina
United States	Translational Reseach Group Inc Dba Providence Clinical Research	North Hollywood	California
United States	Affinity Health	Oak Brook	Illinois
United States	Conquest Research, Llc	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Gb Family Care	Phoenix	Arizona
United States	Clinical Investigations of Texas	Plano	Texas
United States	Progressive Medical Research	Port Orange	Florida
United States	Prospective Research Innovations Inc	Rancho Cucamonga	California
United States	Clinical Trials of Texas Inc (Ctt)	San Antonio	Texas
United States	Quality Research Inc	San Antonio	Texas
United States	Shoals Medical Trials Inc	Sheffield	Alabama
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinical Research Institute of Arizona Llc	Surprise	Arizona
United States	Clinical Research of West Florida	Tampa	Florida
United States	Noble Clinical Research Llc	Tucson	Arizona
United States	Chase Medical Research Llc	Waterbury	Connecticut
United States	Professional Research Network of Kansas Llc	Wichita	Kansas
United States	Conquest Research (Winter Park)	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in WOMAC Pain	Change from Baseline in WOMAC Pain	Baseline, Week 12
Secondary	Change from Baseline in WOMAC Pain	Change from Baseline in WOMAC Pain	Baseline, Week 16
Secondary	Change from Baseline in WOMAC Pain	Change from Baseline in WOMAC Pain	Baseline, Week 20
Secondary	Change from Baseline in WOMAC Pain	Change from Baseline in WOMAC Pain	Baseline, Week 24
Secondary	Change from Baseline in WOMAC Pain	Change from Baseline in WOMAC Pain	Baseline, Week 36
Secondary	Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)	Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)	Baseline, Week 12
Secondary	PGIC	Patient Global Impression of Change	Week 12
Secondary	Total rescue acetaminophen consumption	Total rescue acetaminophen consumption	through Week 12
Secondary	Durable responder with =30% decrease in WOMAC Pain from Baseline	Durable responder with =30% decrease in WOMAC Pain from Baseline	Weeks 4 through 12
Secondary	Change from Baseline in WOMAC Function	Change from Baseline in WOMAC Function	Baseline, Week 36
Secondary	PGIC	Patient Global Impression of Change	Week 36
Secondary	Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)	Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)	Baseline, Week 12
Secondary	Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)	Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)	Baseline, Week 52