|
You Are Here: IC Network > News Room Cystistat Clinical Trials Begin in the United StatesClinical Trial may pave the way for US Registration of this IC treatment.Update: January 2003 - This trial is now closed and is no longer accepting new patients.Bioniche Life Sciences, Inc., a Canadian biopharmaceutical company, has received FDA approval to begin a multi-center, placebo-controlled study of Cystistat (sodium hyaluronate) for the treatment of interstitial cystitis (IC). The study will evaluate the safety and effectiveness of intravesical sodium hyaluronate (Cystistat) compared to placebo in the treatment of IC. Patients who meet the inclusion/exclusion criteria (cystoscopy and urodynamic evaluation within one year of study entry) will be randomized to active treatment (Cystistat) or placebo and will be treated once a week for six weeks. Patients will be required to return for outcome and follow-up assessments at 8, 12 and 16 weeks. Cystistat is approved
for sale in Canada and Europe as a medical device for the temporary replacement
of the glycosaminoglycan (GAG) layer of the bladder. Intravesical administration
of sodium hyaluronate is thought to act by direct contact with the defective
mucosal lining of the bladder (a widely accepted theory for the cause
of IC symptoms) and replacing the deficient GAG. Previous open label studies
of Cystistatâ have demonstrated effectiveness in relieving symptoms
associated with IC. Please check www.bioniche.com in their Clinical Development section for more information regarding this clinical trial. Site Map / Become an ICN Subscriber / ICN Home / Search Our Site The Interstitial Cystitis Network URL: www.ic-network.com All rights reserved. Copyright © 1995-2003
|