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

2019-10-17 11:03:48 | BioPortfolio


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


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 with Placebo and DSP through Week 52.

Study Design


Osteoarthritis of the Knee


TLC599, DSP, Normal Saline


Not yet recruiting


Taiwan Liposome Company

Results (where available)

View Results


Published on BioPortfolio: 2019-10-17T11:03:48-0400

Clinical Trials [3177 Associated Clinical Trials listed on BioPortfolio]

A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee

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.

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

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 k...

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee

This study is a single-center, Phase 2, open-label, 1-period, parallel study with 8 cohorts of subjects with OA of the knee sequentially enrolled to receive single-dose of TLC599 or DSP vi...

Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial

To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the curre...

Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo...

PubMed Articles [6374 Associated PubMed Articles listed on BioPortfolio]

Towards reaching consensus on hyaluronic acid efficacy in knee osteoarthritis.

Intra-articular injection of hyaluronic acid (HA) is a controversial treatment for knee osteoarthritis (OA). While clinical efficacy of HA relative to saline injections has been demonstrated in many s...

Intra-articular botulinum toxin type A for treatment of knee osteoarthritis: Clinical trial.

In recent years, there is a growing interest in new medical applications of botulinum toxin, including pain control, osteoarthritis treatment, and wound healing. While clinical applications of botulin...

The clinical and radiographic course of early knee and hip osteoarthritis over 10 years in CHECK (Cohort Hip and Cohort Knee).

To describe the radiographic and symptomatic course in subjects with hip or knee complaints suspected of early osteoarthritis (OA).

'Acute Flare-Ups' In Patients With, Or At High Risk Of, Knee Osteoarthritis: A Daily Diary Study With Case-Crossover Analysis.

To determine the natural history of flare-ups in knee osteoarthritis and their relation to physical exposures.

Knee adduction moments are not increased in obese knee osteoarthritis patients during stair negotiation.

Negotiating stairs is an important activity of daily living that is also associated with large loads on the knee joint. In medial compartment knee osteoarthritis, the knee adduction moment during leve...

Medical and Biotech [MESH] Definitions

Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

A region of the lower extremity immediately surrounding and including the KNEE JOINT.

More From BioPortfolio on "Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain"

Quick Search

Relevant Topics

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Arthritis is by definition the inflammation of one or more joints, characterized by swelling, pain, warmth, redness and diminished range of joint movement (Oxford Medical Dictionary). There are many different types; Noninflammatory; Osteoarthritis, N...

Searches Linking to this Trial