Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

NCT00517868 | Terminated Phase 2 Results

• 1 other identifier: URG101-104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Painful Bladder Syndrome; Interstitial Cystitis; Bladder Pain Syndrome

Keywords

bladder; pain; urgency; frequency

Outcome Measures

Primary Outcomes (1)

• 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.

  Through 12 hours

Secondary Outcomes (3)

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

  Through 12 hours

• Change in Total Symptom Score

  Through 12 hours

• Change in Daytime Urinary Urgency Score

  Through 12 hours

Study Arms (2)

Crossover

OTHER

Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2

Drug: URG101; Drug: Placebo

Crossover 2

OTHER

URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2

Drug: URG101; Drug: Placebo

Interventions

URG101 DRUG

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.

Crossover; Crossover 2

Placebo DRUG

Liquid formulation without active URG101 drug components

Crossover; Crossover 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urigen: lead

Study Sites (6)

Citrus Valley Medical Research

Glendora, California, 91741, United States

Location

SD Uro-Research

San Diego, California, 92103, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Scripps Clinic Medical Group

San Diego, California, 92130, United States

Location

Georgia Urology

Cartersville, Georgia, 30120, United States

Location

Urology San Antonio Research, P.A.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14.

  PMID: 22082303 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial; Pain

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was intended to include 40 subjects, but it had to be terminated early because the Food and Drug Administration (FDA) unexpectedly recalled the heparin used in the trial due to a possible contamination. Of the 28 subjects enrolled, limited demographic information is available, and the available data are reported for all subjects as a single group. Of the 28 subjects enrolled, there were 18 evaluable full-crossover subjects for the statistical analysis.

Results Point of Contact

• Title: CEO
• Organization: Vaneltix Pharma, Inc.

info@vaneltix.com

732-354-3217

Study Officials

• Jeff Proctor, M.D.

  Georgia Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: August 28, 2007
• Primary Completion: February 28, 2008
• Study Completion: February 28, 2008
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)