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The purpose of this study is primarily to evaluate the safety and tolerability of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.
Approximately 12 patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral) anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period.
Following informed consent procedures, a Screening Visit is done to check general health and determine eligibility for the study. Maximum duration of participation, including a screening period of up to 14 days, will be 44 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Centre for Applied Urological Research
Published on BioPortfolio: 2014-08-27T03:12:42-0400
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