Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

August 20, 2024 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

Terminated

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

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
Measure Description
Time Frame
Change in Daytime Bladder Pain Intensity
Time Frame: Through 12 hours
A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Through 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire
Time Frame: Through 12 hours
Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).
Through 12 hours
Change in Total Symptom Score
Time Frame: Through 12 hours
A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
Through 12 hours
Change in Daytime Urinary Urgency Score
Time Frame: Through 12 hours
A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
Through 12 hours

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 28, 2007

Primary Completion (Actual)

February 28, 2008

Study Completion (Actual)

February 28, 2008

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimated)

August 17, 2007

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URG101-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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