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Achieve is conducting a Phase III, randomized, placebo-controlled study to evaluate the safety and effectiveness of a new viscoelastic hydrogel, for the treatment of osteoarthritis of the knee.
Birmingham, AL (PRWEB) July 15, 2014
*To see if you qualify for this OA Clinical Trial in Birmingham, visit Achieve Clinical Research on the web (http://www.achieveclinical.com/) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is a prospective, Phase III, randomized, double-blind (third party administration with blinded-evaluators), placebo-controlled, pivotal clinical study to evaluate the safety and effectiveness of a new viscoelastic hydrogel for the treatment of pain associated with symptomatic OA of the knee with 26 weeks of follow-up after the first injection.
Approximately 332 subjects will be randomized in this study at multiple investigator sites. A period of approximately 18 months is anticipated from the time the first subject is enrolled to the completion of the last subject visit (last subject out). Individual subject participation will last approximately 6 months.
BACKGROUND & RATIONALE
Hyaluronan (HA), is a naturally occurring linear polysaccharide composed of repeating disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine. HA is synthesized by the chondrocytes in the cartilage and by the type B synoviocytes in the synovial lining. The HA synthesized by the former becomes integrated in the cartilage matrix whereas the latter is released into the joint cavity, where it plays a functional role (lubricating and cushioning properties during joint movement).
Osteoarthritis (OA) of the knee is a common degenerative arthropathy and a leading cause of disability in older adults. Although OA is quite heterogeneous in its clinical aspects, typical clinical features include chronic pain, inflammation, stiffness, and limitation of motion, bone deformity, and ultimately overall functional impairment of the involved joint when the disease is progressive. The disease is characterized by a reduction in the lubricating and viscoelastic properties of the synovial fluid, due to a reduction of the concentration and molecular weight of HA, accompanied by progressive destruction of the cartilage surface.
Clinical studies have demonstrated that weekly Hyalgan injections once a week for 3 to 5 weeks significantly improve pain and functional status in subjects with knee OA. The effect is delayed but progressive over time: the maximum benefit is reached 21 to 28 days after the first injection. After treatment has been completed, the effect lasts up to 6 months and up to 1 year in some subjects. Since this new hydrogel has higher viscosity and elasticity in solution than Hyalgan, similar effects on knee OA are expected with a regimen of a reduced number of injections.
To evaluate the effectiveness of two 3 mL IA injections of this new hydrogel in comparison with two 3 mL IA injections of a placebo in providing superior pain relief for the treatment of subjects with symptomatic primary OA of the knee as measured by the WOMAC Pain Subscale.
Subjects must meet all of the following inclusion criteria to be eligible:
*Achieve Clinical Research conducts Phase II-IV Clinical Research Studies in Alabama. For more information about participating in an Osteoarthritis Clinical Study, please visit our website or contact us directly at (205) 380-6434.
For the original version on PRWeb visit: http://www.prweb.com/releases/2014/07/prweb11997848.htm
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