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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03005873
Registration number
NCT03005873
Ethics application status
Date submitted
12/12/2016
Date registered
29/12/2016
Date last updated
22/04/2024
Titles & IDs
Public title
Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients
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Scientific title
A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee
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Secondary ID [1]
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TLC599A2003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TLC599 LD group
Treatment: Drugs - Normal Saline
Treatment: Drugs - TLC599 HD group
Experimental: TLC599 LD group - 12 mg DSP with 100 µmol PL (1.0 mL)
Experimental: TLC599 HD group - 18 mg DSP with 150 µmol PL (1.5 mL)
Placebo Comparator: Placebo group - 1.5 mL normal saline
Treatment: Drugs: TLC599 LD group
Single dose via intra-articular injection
Treatment: Drugs: Normal Saline
Single dose via intra-articular injection
Treatment: Drugs: TLC599 HD group
Single dose via intra-articular injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in WOMAC Pain Subscale at Week 12
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Assessment method [1]
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The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale.
Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome).
Missing data were imputed.
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Timepoint [1]
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Baseline, Week 12
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Eligibility
Key inclusion criteria
Main
1. Male or female patients, at least 50 years of age.
2. Documented diagnosis of OA of the knee for at least 6 months
3. The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades
4. Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at
baseline.
5. Willing and able to comply with study procedures and provide written informed consent.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients who received systemic corticosteroids within the last 30 days prior to
dosing.
2. Patients who use prohibited medications within 7 days prior to study drug
administration or any pain control medication including acetaminophen within 48 hours
prior to study drug administration.
3. Patients who use prohibited medications other than acetaminophen and oral NSAIDs from
screening visit to 7 days prior to study drug administration.
4. Documented history and confirmed autoimmune disease
5. History of post-traumatic knee arthritis, or evidence of intra articular bleeding of
the study knee
6. History of infective arthritis
7. Unstable study knee joint
8. Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee
within 3 months prior to the screening visit.
9. A history of treated malignancy which is disease free for = 5 years prior to the
screening visit
10. Uncontrolled and unstable concurrent medical or psychiatric illness, that will
jeopardize the safety of the patient
11. Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory
diseases within 6 months prior to the screening visit.
12. Current use of anticoagulants, including warfarin, heparin, low molecular weight
heparin, or dabigatran.
13. Abnormalities of laboratory parameters as described below will qualify for exclusion:
- hemoglobin < 8 g/dL;
- total white blood cell count < 4000/ µL;
- serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase > 2 times
upper limit of normal (ULN) for the laboratory reference ranges;
- serum creatinine > 2 times ULN for the laboratory reference range;
- serum uric acid > ULN for the laboratory reference range;
- prothrombin time/International Normalized Ratio > ULN for the laboratory
reference range.
14. Contraindication to undergoing magnetic resonance imaging (MRI)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/07/2018
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Sample size
Target
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Genesis Research Services Pty Limited - Broadmeadow
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Recruitment hospital [2]
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Pendlebury Clinic Private Hospital - Cardiff
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Recruitment hospital [3]
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Footscray Hospital- Western Health - Footscray
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Recruitment hospital [4]
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Linear Clinical Research Limited - Nedlands,
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Recruitment hospital [5]
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Royal North Shore Hospital - Sydney
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Recruitment postcode(s) [1]
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- Broadmeadow
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Recruitment postcode(s) [2]
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2285 - Cardiff
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Recruitment postcode(s) [3]
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- Footscray
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Recruitment postcode(s) [4]
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- Nedlands,
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Recruitment postcode(s) [5]
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- Sydney
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Recruitment outside Australia
Country [1]
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Taiwan
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State/province [1]
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Changhua
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Country [2]
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Taiwan
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State/province [2]
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Kaohsiung
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Country [3]
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Taiwan
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State/province [3]
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Taichung
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Country [4]
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Taiwan
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State/province [4]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Taiwan Liposome Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study
to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03005873
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Yvonne Shih, PhD
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Address
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Taiwan Liposome Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03005873
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