Interstitial Cystitis Clinical Trial
Official title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
The purpose of this study is to determine if the combination product (URG101) is safe and effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and double-blinded such that neither the subject nor doctor will know which drug or placebo is received.
This is a Phase 2a, randomized, double-blind, placebo controlled, multicenter, single-dose,
pharmacokinetic study designed to determine the efficacy and safety of the combination
product (URG101) compared with its individual components (Heparin Sodium and Lidocaine
Hydrochloride).
Eligible subjects exhibiting moderate to severe symptoms of bladder pain associated with
their diagnosis of interstitial cystitis/bladder pain syndrome who have signed informed
consent, will be screened and provisionally enrolled for intravesical treatment.
On the day of study drug administration subjects will be randomized (2:1:2:1;
URG101:placebo:lidocaine:heparin) and will receive a single administration of one of four
intravesical treatments in a blinded fashion, based on random assignment:
1. URG101 (buffered lidocaine-heparin)
2. Placebo (phosphate buffer)
3. Lidocaine hydrocholoride buffered alone
4. Heparin sodium buffered alone
Efficacy and safety assessments will be completed for 24 hours after study drug
administration. End of Study Follow-up will be completed by telephone 48 to 72 hours after
study drug administration.
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