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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00256542
Date of registration: 17/11/2005
Prospective Registration: Yes
Primary sponsor: Urigen
Public title: Study of U101 for Bladder Pain and/or Urgency
Scientific 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
Date of first enrolment: January 2006
Target sample size: 90
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00256542
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     C. Lowell Parsons, MD
Address: 
Telephone:
Email:
Affiliation:  UCSD
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Pelvic Pain
Bladder Diseases
Interstitial Cystitis
Intervention(s)
Drug: Alkalinized Lidocaine-Heparin
Primary Outcome(s)
Overall improvement in combined symptoms of pain and urgency at 3 weeks
Secondary Outcome(s)
Reduction in O'Leary-Sant score at 3 weeks
Reduction in pain on ten point scale at 3 weeks
Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
Safety
Reduction in urgency on ten point scale at 3 weeks
Change in number of voids/24 hours
Change in average void volume
Secondary ID(s)
URG-101
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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