Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of U101 for Bladder Pain and/or Urgency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00256542
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : September 29, 2006
Sponsor:
Information provided by:
Urigen

Tracking Information
First Submitted Date  ICMJE November 17, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date September 29, 2006
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
Overall improvement in combined symptoms of pain and urgency at 3 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
Overall improvement in combined symptoms of pain and urgency at 3 weeks.
Change History Complete list of historical versions of study NCT00256542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of U101 for Bladder Pain and/or Urgency
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Pain
  • Interstitial Cystitis
  • Bladder Diseases
Intervention  ICMJE Drug: Alkalinized Lidocaine-Heparin
Study Arms  ICMJE Not Provided
Publications * Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 17, 2005)
90
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256542
Other Study ID Numbers  ICMJE URG-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Urigen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: C. Lowell Parsons, MD UCSD
PRS Account Urigen
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP