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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04123561




Registration number
NCT04123561
Ethics application status
Date submitted
9/10/2019
Date registered
11/10/2019
Date last updated
13/04/2020

Titles & IDs
Public title
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Scientific 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
Secondary ID [1] 0 0
TLC599A3005
Universal Trial Number (UTN)
Trial acronym
EXCELLENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TLC599
Treatment: Drugs - DSP
Other interventions - Normal Saline

Experimental: TLC599 - TLC599 (1mL) IA injection

Active Comparator: Dexamethasone sodium phosphate - DSP 4mg (1mL) IA injection

Placebo Comparator: Normal Saline - Normal saline (1mL) IA injection


Treatment: Drugs: TLC599
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)

Treatment: Drugs: 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 interventions: Normal Saline
0.9% normal saline

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in WOMAC Pain - Change from Baseline in WOMAC Pain
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Change from Baseline in WOMAC Pain - Change from Baseline in WOMAC Pain
Timepoint [1] 0 0
up to Week 52
Secondary outcome [2] 0 0
Change from Baseline in WOMAC Function - Change from Baseline in WOMAC Function
Timepoint [2] 0 0
up to Week 52
Secondary outcome [3] 0 0
Patient Global Impression of Change (PGIC) - Patient Global Impression of Change (PGIC)
Timepoint [3] 0 0
up to Week 52
Secondary outcome [4] 0 0
Consistent responder status defined as WOMAC Pain score <1.2 - Consistent responder status defined as WOMAC Pain score <1.2 0-4
Timepoint [4] 0 0
Week 16, Week 40

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [3] 0 0
Northern Sydney Local Health District - Saint Leonards
Recruitment hospital [4] 0 0
Austrials - Taringa
Recruitment hospital [5] 0 0
Colin Bayliss Research and Teaching Unit - Victoria Park
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2292 - Saint Leonards
Recruitment postcode(s) [4] 0 0
4068 - Taringa
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Taiwan Liposome Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Trial website
https://clinicaltrials.gov/show/NCT04123561
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carl Brown, PhD
Address 0 0
Taiwan Liposome Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cynthia LIN
Address 0 0
Country 0 0
Phone 0 0
+886 2 2655 7377
Fax 0 0
Email 0 0
cynthia_lin@tlcbio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04123561