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Trial record 2 of 4 for:    Taiwan Liposome Company | Knee Osteoarthritis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123561
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Taiwan Liposome Company

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: TLC599 Drug: DSP Other: Normal Saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: TLC599
TLC599 (1mL) IA injection
Drug: TLC599
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Other Name: TLC599 Injection

Active Comparator: Dexamethasone sodium phosphate
DSP 4mg (1mL) IA injection
Drug: TLC599
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Other Name: TLC599 Injection

Drug: 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 Name: Dexamethasone Sodium Phosphate

Placebo Comparator: Normal Saline
Normal saline (1mL) IA injection
Other: Normal Saline
0.9% normal saline




Primary Outcome Measures :
  1. Change from Baseline in WOMAC Pain [ Time Frame: Baseline, Week 16 ]
    Change from Baseline in WOMAC Pain


Secondary Outcome Measures :
  1. Change from Baseline in WOMAC Pain [ Time Frame: up to Week 52 ]
    Change from Baseline in WOMAC Pain

  2. Change from Baseline in WOMAC Function [ Time Frame: up to Week 52 ]
    Change from Baseline in WOMAC Function

  3. Patient Global Impression of Change (PGIC) [ Time Frame: up to Week 52 ]
    Patient Global Impression of Change (PGIC)

  4. Consistent responder status defined as WOMAC Pain score <1.2 [ Time Frame: Week 16, Week 40 ]
    Consistent responder status defined as WOMAC Pain score <1.2 0-4



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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): NCT04123561


Contacts
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Contact: Cynthia LIN +886 2 2655 7377 cynthia_lin@tlcbio.com

Locations
Show Show 45 study locations
Sponsors and Collaborators
Taiwan Liposome Company
Investigators
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Study Director: Carl Brown, PhD Taiwan Liposome Company
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Responsible Party: Taiwan Liposome Company
ClinicalTrials.gov Identifier: NCT04123561    
Other Study ID Numbers: TLC599A3005
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action