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Trial record 52 of 427 for:    Taipei Medical University Hospital

Single-Dose Administration Trial of TLC599 in Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT02803307
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Taiwan Liposome Company

Brief Summary:
This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: TLC599 Phase 1 Phase 2

Detailed Description:

Protocol No: TLC599A1001

Name of Finished Product: TLC599

Title of Study:

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee

Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Study duration:

The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration Trial of TLC599 in Subjects With Osteoarthritis of the Knee
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 6 mg TLC599
6 mg DSP with 50 μmol PL
Drug: TLC599
Single dose via intra-articular injection

Experimental: 12 mg TLC599
12 mg DSP with 100 μmol PL
Drug: TLC599
Single dose via intra-articular injection




Primary Outcome Measures :
  1. Safety parameters [ Time Frame: up to 12 weeks after dosing ]
    Safety parameters will be assessed as measured by adverse events (AEs), changes in physical examinations, vital signs, and clinical laboratory results


Secondary Outcome Measures :
  1. Pain score (VAS) [ Time Frame: Questionnaire will be collected at baseline, Week 1, Week 4, Week 8, Week 12. ]
  2. WOMAC questionnaire [ Time Frame: Questionnaire will be collected at baseline, Week 1, Week 4, Week 8, Week 12. ]
  3. IGART questionnaire [ Time Frame: Questionnaire will be collected at Week 1, Week 4, Week 8, Week 12. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, at least 20 years of age
  2. Documented diagnosis of OA of the knee for at least 6 months
  3. At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale
  4. VAS score of ≥ 4 at baseline

Exclusion Criteria:

  1. Subjects who received systemic corticosteroids for the last 30 days prior to baseline
  2. Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline
  3. History of rheumatoid arthritis or other autoimmune disease
  4. Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing
  5. History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee
  6. Concurrent systemic active or uncontrolled infectious disease
  7. A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix)
  8. History of acquired or congenital immunodeficiency diseases
  9. Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia
  10. Stroke or myocardial infarction within 3 months prior to the screening visit
  11. Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit
  12. Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period
  13. Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space
  14. Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803307


Locations
Taiwan
MacKay Memorial Hospital
Taipei, Taiwan, 104
Taipei Medical University Hospital
Taipei, Taiwan, 110
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taiwan Liposome Company

Responsible Party: Taiwan Liposome Company
ClinicalTrials.gov Identifier: NCT02803307     History of Changes
Other Study ID Numbers: TLC599A1001
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Taiwan Liposome Company:
osteoarthritis of the knee
TLC599
Dexamethasone
DSP

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases