Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Phase 2TerminatedNCT00517868

Urigen28 enrolled

Overview

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Painful Bladder Syndrome Interstitial Cystitis Bladder Pain Syndrome

Interventions

URG101DRUG

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.

PlaceboDRUG

Liquid formulation without active URG101 drug components

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Citrus Valley Medical Research

Glendora, California, United States

SD Uro-Research

San Diego, California, United States

University of California, San Diego

San Diego, California, United States

Scripps Clinic Medical Group

San Diego, California, United States

Outcomes

Primary Outcomes

Change in Daytime Bladder Pain Intensity

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.

Time frame: Through 12 hours

Secondary Outcomes

Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire

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).

Time frame: Through 12 hours

Change in Total Symptom Score

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'.

Time frame: Through 12 hours

Change in Daytime Urinary Urgency Score

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'.

Data from ClinicalTrials.gov

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