Back to resultsStudy of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Primary Purpose
Painful Bladder Syndrome, Interstitial Cystitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
URG101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Painful Bladder Syndrome focused on measuring bladder, pain, urgency, frequency
Eligibility 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
Sites / Locations
- Citrus Valley Medical Research
- SD Uro-Research
- University of California, San Diego
- Scripps Clinic Medical Group
- Georgia Urology
- Urology San Antonio Research, P.A.
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Crossover
Crossover 2
Arm Description
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
Outcomes
Primary Outcome Measures
Average % Change in Daytime Bladder Pain Score
Secondary Outcome Measures
PORIS - Question 3 - ≥50% Overall Improvement
Average % Change in Total Symptom Score (pain + urge)
Average % Change in Daytime Urinary Urgency Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00517868
Brief Title
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urigen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Bladder Syndrome, Interstitial Cystitis
Keywords
bladder, pain, urgency, frequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crossover
Arm Type
Other
Arm Description
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
Arm Title
Crossover 2
Arm Type
Other
Arm Description
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
Intervention Type
Drug
Intervention Name(s)
URG101
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Liquid formulation without active URG101 drug components
Primary Outcome Measure Information:
Title
Average % Change in Daytime Bladder Pain Score
Time Frame
T0 - 12hr
Secondary Outcome Measure Information:
Title
PORIS - Question 3 - ≥50% Overall Improvement
Time Frame
T 0.5hr
Title
Average % Change in Total Symptom Score (pain + urge)
Time Frame
T0 - 12hr
Title
Average % Change in Daytime Urinary Urgency Score
Time Frame
T0-12hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Proctor, M.D.
Organizational Affiliation
Georgia Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citrus Valley Medical Research
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
SD Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Scripps Clinic Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Georgia Urology
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Facility Name
Urology San Antonio Research, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
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