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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.
Osteoarthritis of the Knee
TLC599, DSP, Normal Saline
Not yet recruiting
Taiwan Liposome Company
Published on BioPortfolio: 2019-10-17T11:03:48-0400
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.
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...
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...
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...
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...
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...
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...
To describe the radiographic and symptomatic course in subjects with hip or knee complaints suspected of early osteoarthritis (OA).
To determine the natural history of flare-ups in knee osteoarthritis and their relation to physical exposures.
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...
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.
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...
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...