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Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517868
First Posted: August 17, 2007
Last Update Posted: April 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Urigen
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Urigen:

Primary Outcome Measures:
  • Average % Change in Daytime Bladder Pain Score [ Time Frame: T0 - 12hr ]

Secondary Outcome Measures:
  • PORIS - Question 3 - ≥50% Overall Improvement [ Time Frame: T 0.5hr ]
  • Average % Change in Total Symptom Score (pain + urge) [ Time Frame: T0 - 12hr ]
  • Average % Change in Daytime Urinary Urgency Score [ Time Frame: T0-12hr ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517868


Locations
United States, California
Citrus Valley Medical Research
Glendora, California, United States, 91741
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
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: Dennis Giesing, PhD, Chief Scientific Officer, Urigen Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00517868     History of Changes
Other Study ID Numbers: URG101-104
First Submitted: August 15, 2007
First Posted: August 17, 2007
Last Update Posted: April 10, 2008
Last Verified: April 2008

Keywords provided by Urigen:
bladder
pain
urgency
frequency

Additional relevant MeSH terms:
Syndrome
Pain
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases


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