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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TLC599
DSP
Normal Saline
Sponsored by
Taiwan Liposome Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cahaba Research, Inc
  • Affinity Orthopedic Specialists Llc
  • Shoals Medical Trials Inc
  • Gb Family Care
  • Arizona Research Center
  • Clinical Research Institute of Arizona Llc
  • Noble Clinical Research Llc
  • Biosolutions Clinical Research Center
  • Translational Reseach Group Inc Dba Providence Clinical Research
  • Prospective Research Innovations Inc
  • Encompass Clinical Research
  • Chase Medical Research Llc
  • Tampa Bay Medical Research
  • University Clinical Research-Deland, Llc Dba Accel Clinical Research
  • Jacksonville Center For Clinical Research
  • Charter Research, Llc
  • Well Pharma Medical Research Corp
  • Conquest Research, Llc
  • Progressive Medical Research
  • Clinical Research of West Florida
  • Conquest Research (Winter Park)
  • Drug Studies America
  • Georgia Institute For Clinical Research Llc
  • Better Health Clinical Research Inc
  • Chicago Clinical Research Institute, Inc.
  • Northwestern University
  • Healthcare Research Network Ii, Llc
  • Affinity Health
  • Medisphere Medical Research Center Llc
  • Professional Research Network of Kansas Llc
  • Delricht Research
  • Healthcare Research Network
  • Albuquerque Clinical Trials, Inc.
  • Drug Trials America
  • Lillestol Research Llc
  • Altoona Center For Clinical Research
  • Lowcountry Orthopedics C/O Coastal Carolina research center
  • Clinical Investigations of Texas
  • Quality Research Inc
  • Clinical Trials of Texas Inc (Ctt)
  • Charlottesville Medical Research Center Llc
  • Genesis Research Services
  • Australian Clinical Research Network
  • Northern Sydney Local Health District
  • Austrials
  • Colin Bayliss Research and Teaching Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

TLC599

Dexamethasone sodium phosphate

Normal Saline

Arm Description

TLC599 (1mL) IA injection

DSP 4mg (1mL) IA injection

Normal saline (1mL) IA injection

Outcomes

Primary Outcome Measures

Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain

Secondary Outcome Measures

Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
Change from Baseline in WOMAC Pain
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)
PGIC
Patient Global Impression of Change
Total rescue acetaminophen consumption
Total rescue acetaminophen consumption
Durable responder with ≥30% decrease in WOMAC Pain from Baseline
Durable responder with ≥30% decrease in WOMAC Pain from Baseline
Change from Baseline in WOMAC Function
Change from Baseline in WOMAC Function
PGIC
Patient Global Impression of Change
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)
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)

Full Information

First Posted
October 9, 2019
Last Updated
August 8, 2022
Sponsor
Taiwan Liposome Company
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1. Study Identification

Unique Protocol Identification Number
NCT04123561
Brief Title
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
February 3, 2022 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Liposome Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TLC599
Arm Type
Experimental
Arm Description
TLC599 (1mL) IA injection
Arm Title
Dexamethasone sodium phosphate
Arm Type
Active Comparator
Arm Description
DSP 4mg (1mL) IA injection
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline (1mL) IA injection
Intervention Type
Drug
Intervention Name(s)
TLC599
Other Intervention Name(s)
TLC599 Injection
Intervention Description
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Intervention Type
Drug
Intervention Name(s)
DSP
Other Intervention Name(s)
Dexamethasone Sodium Phosphate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
0.9% normal saline
Primary Outcome Measure Information:
Title
Change from Baseline in WOMAC Pain
Description
Change from Baseline in WOMAC Pain
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in WOMAC Pain
Description
Change from Baseline in WOMAC Pain
Time Frame
Baseline, Week 16
Title
Change from Baseline in WOMAC Pain
Description
Change from Baseline in WOMAC Pain
Time Frame
Baseline, Week 20
Title
Change from Baseline in WOMAC Pain
Description
Change from Baseline in WOMAC Pain
Time Frame
Baseline, Week 24
Title
Change from Baseline in WOMAC Pain
Description
Change from Baseline in WOMAC Pain
Time Frame
Baseline, Week 36
Title
Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)
Description
Change from Baseline in WOMAC Function at Week 12 (Group A vs. Group C)
Time Frame
Baseline, Week 12
Title
PGIC
Description
Patient Global Impression of Change
Time Frame
Week 12
Title
Total rescue acetaminophen consumption
Description
Total rescue acetaminophen consumption
Time Frame
through Week 12
Title
Durable responder with ≥30% decrease in WOMAC Pain from Baseline
Description
Durable responder with ≥30% decrease in WOMAC Pain from Baseline
Time Frame
Weeks 4 through 12
Title
Change from Baseline in WOMAC Function
Description
Change from Baseline in WOMAC Function
Time Frame
Baseline, Week 36
Title
PGIC
Description
Patient Global Impression of Change
Time Frame
Week 36
Title
Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)
Description
Change from Baseline in WOMAC Pain at Week 12 (Group A vs. Group B)
Time Frame
Baseline, Week 12
Title
Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)
Description
Change from Baseline in WOMAC Pain at Week 52 (Group A vs. Group C)
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Brown, PhD
Organizational Affiliation
Taiwan Liposome Company
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Research, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Affinity Orthopedic Specialists Llc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Shoals Medical Trials Inc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Gb Family Care
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Clinical Research Institute of Arizona Llc
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Noble Clinical Research Llc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Biosolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
919142
Country
United States
Facility Name
Translational Reseach Group Inc Dba Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Prospective Research Innovations Inc
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Chase Medical Research Llc
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
University Clinical Research-Deland, Llc Dba Accel Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
33216
Country
United States
Facility Name
Charter Research, Llc
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Well Pharma Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Conquest Research, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Conquest Research (Winter Park)
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Institute For Clinical Research Llc
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Better Health Clinical Research Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Chicago Clinical Research Institute, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Healthcare Research Network Ii, Llc
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Affinity Health
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Medisphere Medical Research Center Llc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Professional Research Network of Kansas Llc
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Delricht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Healthcare Research Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Lillestol Research Llc
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Lowcountry Orthopedics C/O Coastal Carolina research center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Clinical Investigations of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Quality Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Clinical Trials of Texas Inc (Ctt)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Charlottesville Medical Research Center Llc
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Genesis Research Services
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Northern Sydney Local Health District
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Austrials
City
Taringa
State/Province
Queensland
ZIP/Postal Code
4068
Country
Australia
Facility Name
Colin Bayliss Research and Teaching Unit
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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