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NCT00517868 Clinical Trial

Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Interstitial Cystitis Clinical Trial

Official title:
URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517868
Other study ID # URG101-104
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2007
Est. completion date April 2008

Study information
Verified date October 2018
Source Urigen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• URG101
Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
• Placebo
Liquid formulation without active URG101 drug components

Locations
Country Name City State
United States Georgia Urology Cartersville Georgia
United States Citrus Valley Medical Research Glendora California
United States Urology San Antonio Research, P.A. San Antonio Texas
United States Scripps Clinic Medical Group San Diego California
United States SD Uro-Research San Diego California
United States University of California, San Diego San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Urigen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average % Change in Daytime Bladder Pain Score T0 - 12hr
Secondary PORIS - Question 3 - =50% Overall Improvement T 0.5hr
Secondary Average % Change in Total Symptom Score (pain + urge) T0 - 12hr
Secondary Average % Change in Daytime Urinary Urgency Score T0-12hr
See also
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