Study of U101 for Bladder Pain and/or Urgency

This study has been completed.
Sponsor:
Information provided by:
Urigen
ClinicalTrials.gov Identifier:
NCT00256542
First received: November 17, 2005
Last updated: September 28, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Pelvic Pain
Interstitial Cystitis
Bladder Diseases
Drug: Alkalinized Lidocaine-Heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Urigen:

Primary Outcome Measures:
  • Overall improvement in combined symptoms of pain and urgency at 3 weeks

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 90
Study Start Date: January 2006
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256542

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
United States, Georgia
Georgia Urology
Cartersville, Georgia, United States, 30120
United States, Illinois
St. Mary's Good Samaritan
Centralia, Illinois, United States, 62801
United States, Kansas
The Urogynecology Center
Overland Park, Kansas, United States, 66215
United States, Michigan
Mid-Michigan Health Centers
Jackson, Michigan, United States, 49201
United States, New York
Central Park Urology
New York City, New York, United States, 10019
United States, North Carolina
The Urology Center
Greensboro, North Carolina, United States, 27403
United States, Oklahoma
Urologic Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Whitmore Urology Office
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
Urigen
Investigators
Principal Investigator: C. Lowell Parsons, MD UCSD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00256542     History of Changes
Other Study ID Numbers: URG-101
Study First Received: November 17, 2005
Last Updated: September 28, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Urigen:
interstitial cystitis
pelvic pain
urgency
frequency
Pelvic Pain and/or Urgency of Bladder Origin

Additional relevant MeSH terms:
Urinary Bladder Diseases
Cystitis
Pelvic Pain
Cystitis, Interstitial
Urologic Diseases
Pain
Signs and Symptoms
Heparin
Lidocaine
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 28, 2014