Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04123561 · ClinicalTrials.gov registry record · Phase 3
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
A Phase 3 study of Osteoarthritis of the Knee, sponsored by Taiwan Liposome Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
- 20
- Study locations
NCT04123561: Completed Phase 3 study of Osteoarthritis of the Knee, sponsored by Taiwan Liposome Company.
NCT04123561 is a Phase 3 study of Osteoarthritis of the Knee that has completed, run by Taiwan Liposome Company. The registered enrollment target is 504 participants, above the 181-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (178% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04123561, a Phase 3 study of Osteoarthritis of the Knee, has completed, sponsored by Taiwan Liposome Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Primary Outcome
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating grea
Conditions Studied
Interventions
- OTHER Normal Saline
- DRUG TLC599
- DRUG DSP
Study Locations (20)
Florida
- Tampa Bay Medical Research - Clearwater
- University Clinical Research-Deland, Llc Dba Accel Clinical Research - DeLand
- Jacksonville Center For Clinical Research - Jacksonville
- Charter Research, Llc - Lady Lake
- Well Pharma Medical Research Corp - Miami
- Conquest Research, Llc - Orlando
- Progressive Medical Research - Port Orange
- Clinical Research of West Florida - Tampa
Arizona
- Gb Family Care - Phoenix
- Arizona Research Center - Phoenix
- Clinical Research Institute of Arizona Llc - Surprise
- Noble Clinical Research Llc - Tucson
California
- Biosolutions Clinical Research Center - La Mesa
- Translational Reseach Group Inc Dba Providence Clinical Research - North Hollywood
- Prospective Research Innovations Inc - Rancho Cucamonga
- Encompass Clinical Research - Spring Valley
Alabama
- Cahaba Research, Inc - Birmingham
- Affinity Orthopedic Specialists Llc - Birmingham
- Shoals Medical Trials Inc - Sheffield
Connecticut
- Chase Medical Research Llc - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 3 |
What the finished NCT04123561 record still lists
NCT04123561 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (178% higher).
The record links to 1 condition, with Osteoarthritis of the Knee appearing as the primary indexed condition, and to 3 interventions - of which Normal Saline is the first listed.
NCT04123561 names 20 study sites across 5 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04123561 about?
NCT04123561 is a clinical study titled "Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain". Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
What is the current status of trial NCT04123561?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2019-11-26. Estimated completion is 2022-02-03.
What conditions does trial NCT04123561 study?
This clinical trial studies the following conditions: Osteoarthritis of the Knee.
What interventions are being tested in trial NCT04123561?
The interventions under investigation include: Normal Saline (OTHER), TLC599 (DRUG), DSP (DRUG).
Who is sponsoring clinical trial NCT04123561?
This trial is sponsored by Taiwan Liposome Company, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04123561 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis of the Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04123561's enrollment target sits among peer trials
504 1st of 16 higher than 16 of 16 other Osteoarthritis of the Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis of the Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee Marching On for Veterans With Osteoarthritis of the Knee
ACTIVE NOT RECRUITING · Phase 3
-
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
COMPLETED · Phase 3
-
Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee
COMPLETED · Phase 3
-
Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
RECRUITING · Phase 2
-
Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
RECRUITING · NA
-
Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05846282 · 504 participants · NA
Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience
- NCT06072131 · 504 participants · Phase 3
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
- NCT06736522 · 504 participants · NA
Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program
- NCT06822257 · 504 participants · NA
Drinking in Young Adult Duos (DYAD) Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI