Study of U101 for Bladder Pain and/or Urgency

September 28, 2006 updated by: Urigen

A Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravesical Alkalinized Lidocaine-Heparin for the Symptoms of Pelvic Pain and/or Urgency of Bladder Origin

The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

90

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
      • San Diego, California, United States, 92103
        • UCSD Medical Center
    • Georgia
      • Cartersville, Georgia, United States, 30120
        • Georgia Urology
    • Illinois
      • Centralia, Illinois, United States, 62801
        • St. Mary's Good Samaritan
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • The Urogynecology Center
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Mid-Michigan Health Centers
    • New York
      • New York City, New York, United States, 10019
        • Central Park Urology
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • The Urology Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Urologic Specialists of Oklahoma, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Whitmore Urology Office

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 at least 18 years of age.
  • Subjects must have given written informed consent to participate in this trial.
  • All female subjects, except those who are post-menopausal and/or surgically sterilized, must consent to use two medically acceptable methods of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or her partner include: abstinence, birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom and foam, vaginal spermicidal suppository, progestin implant, and Depo-Provera injections.
  • Subjects must have had symptoms of pelvic pain and/or urgency.
  • Medical history and physical examination results must be clinically acceptable to the Investigator. Medical Monitor may evaluate subjects who don't meet eligibility criteria.
  • Female subjects currently using hormone therapy (HT) must have been using HT for at least 3 months.

Exclusion Criteria:

  • Subjects less than 18 years of age.
  • Subjects with known hypersensitivity to heparin or lidocaine.
  • Female subjects who have a positive pregnancy test at the time of screening, who are pregnant or lactating, or who are planning to become pregnant during the study period.
  • Subjects who are chronic users of narcotics or who are using any narcotics at the time of study entry.
  • Subjects who have hepatic disease or clinically significant abnormal liver function tests (more than twice the upper limit of the normal range).
  • Subjects who do not expect to be available for the entire duration of the study.
  • Subjects with any coexisting significant medical condition that is likely to interfere with study procedures (cardiovascular, hematological, central nervous system, pulmonary, renal, etc.)
  • Subjects who have been treated with dimethyl sulfoxide (DMSO) or other bladder instillation therapies within three months prior to study entry.
  • Subjects who have had cystoscopic dilatation of their bladder or urethra within three months of study entry.
  • Subjects who have taken or used any investigational drug or device within 30 days before the start of the study, or who are currently enrolled in another investigational study.
  • Subjects contemplating having or scheduled for any invasive surgical procedures during the study period.
  • Subjects who are unwilling or unable to abide by the requirements of the study.
  • History of gastrointestinal (GI) bleeding
  • Active bleeding from any source
  • Screening activated partial thromboplastin time (aPTT) above normal limits
  • Systolic blood pressure (BP) > 180 mmHg or < 90 mmHg at Screening.
  • Subjects with an actively bleeding lesion/area in the bladder as detected by urinalysis

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall improvement in combined symptoms of pain and urgency at 3 weeks

Secondary Outcome Measures

Outcome Measure
Safety
Reduction in pain on ten point scale at 3 weeks
Reduction in urgency on ten point scale at 3 weeks
Change in number of voids/24 hours
Change in average void volume
Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
Reduction in O'Leary-Sant score at 3 weeks

Collaborators and Investigators

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

Sponsor

Urigen

Investigators

  • Principal Investigator: C. Lowell Parsons, MD, UCSD

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

January 1, 2006

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 29, 2006

Last Update Submitted That Met QC Criteria

September 28, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URG-101

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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