Overview

Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
Summary
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Urigen
Criteria
Inclusion Criteria:

- male and female subjects >= 18 years of age

- moderate to severe symptoms of PBS/IC

- minimum pain/urgency/frequency scores

- female subjects on hormone therapy must be on stable dose for >= 3 months

Exclusion Criteria:

- positive pregnancy test or pregnant or lactating

- narcotics or medical marijuana within 3 months

- use of any investigational drug or device within 30 days

- bacterial cystitis within 30 days