Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis - Full Text View

Sponsored by:	Urigen
Information provided by:	Urigen
ClinicalTrials.gov Identifier:	NCT00517868

Purpose

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

Condition	Intervention	Phase
Painful Bladder Syndrome Interstitial Cystitis	Drug: URG101 Drug: Placebo	Phase II

MedlinePlus related topics: Interstitial Cystitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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.

Further study details as provided by Urigen:

Primary Outcome Measures:

Average % Change in Daytime Bladder Pain Score [ Time Frame: T0 - 12hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PORIS - Question 3 - ≥50% Overall Improvement [ Time Frame: T 0.5hr ] [ Designated as safety issue: No ]
Average % Change in Total Symptom Score (pain + urge) [ Time Frame: T0 - 12hr ] [ Designated as safety issue: No ]
Average % Change in Daytime Urinary Urgency Score [ Time Frame: T0-12hr ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	August 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Crossover Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2	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. Drug: Placebo Liquid formulation without active URG101 drug components
Crossover 2 URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2	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. Drug: Placebo Liquid formulation without active URG101 drug components

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517868

Locations

United States, California
SD Uro-Research
San Diego, California, United States, 92103
University of California, San Diego
San Diego, California, United States, 92103
Scripps Clinic Medical Group
San Diego, California, United States, 92130
Citrus Valley Medical Research
Glendora, California, United States, 91741
United States, Georgia
Georgia Urology
Cartersville, Georgia, United States, 30120
United States, Texas
Urology San Antonio Research, P.A.
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Urigen

Investigators

Principal Investigator:

Jeff Proctor, M.D.

Georgia Urology

More Information

Responsible Party:	Urigen Pharmaceuticals, Inc. ( Dennis Giesing, PhD, Chief Scientific Officer )
Study ID Numbers:	URG101-104
Study First Received:	August 15, 2007
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00517868
Health Authority:	United States: Food and Drug Administration

Keywords provided by Urigen:

bladder
pain
urgency
frequency

Study placed in the following topic categories:

Cystitis, Interstitial
Cystocele
Pelvic Pain
Urologic Diseases

Urinary Bladder Diseases
Cystitis
Pain

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009