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Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by:
Urigen
ClinicalTrials.gov Identifier:
NCT00517868
First received: August 15, 2007
Last updated: April 7, 2008
Last verified: April 2008
History of Changes

August 15, 2007
April 7, 2008
August 2007
April 2008   (final data collection date for primary outcome measure)
Average % Change in Daytime Bladder Pain Score [ Time Frame: T0 - 12hr ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00517868 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
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.

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Painful Bladder Syndrome
  • Interstitial Cystitis
  • 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
    Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
    Interventions:
    • Drug: URG101
    • Drug: Placebo
  • Crossover 2
    URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
    Interventions:
    • Drug: URG101
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00517868
URG101-104
No
Dennis Giesing, PhD, Chief Scientific Officer, Urigen Pharmaceuticals, Inc.
Urigen
Not Provided
Principal Investigator: Jeff Proctor, M.D. Georgia Urology
Urigen
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP