Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

October 16, 2018 updated by: Urigen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average % Change in Daytime Bladder Pain Score
Time Frame: T0 - 12hr
T0 - 12hr

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urigen

Investigators

  • Principal Investigator: Jeff Proctor, M.D., Georgia Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 17, 2007

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URG101-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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