Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Phase 2

Terminated

• Conditions: Bladder Pain Syndrome; Interstitial Cystitis; Painful Bladder Syndrome
• Interventions: Drug: URG101; Drug: Placebo

• Registration Number: NCT00517868
• Lead Sponsor: Urigen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-17
• Study Start: 2007-08-28
• Primary Completion: 2008-02-28
• Study Completion: 2008-02-28
• Disposition First Submitted: 2018-10-09
• Disposition First Submitted QC: 2018-10-09
• Disposition First Posted: 2018-10-11
• Results First Submitted: 2024-05-10
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Results First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover	URG101	Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
Crossover	Placebo	Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
Crossover 2	Placebo	URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
Crossover 2	URG101	URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2

Primary Outcome Measures

Name	Time	Method
Change in Daytime Bladder Pain Intensity	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.

Secondary Outcome Measures

Name	Time	Method
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire	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).
Change in Daytime Urinary Urgency Score	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'.
Change in Total Symptom Score	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'.

Trial Locations

Locations (6)

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

Citrus Valley Medical Research; 🇺🇸 Glendora, California, United States

Georgia Urology; 🇺🇸 Cartersville, Georgia, United States

Urology San Antonio Research, P.A.; 🇺🇸 San Antonio, Texas, United States