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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00256542
Other study ID # URG-101
Secondary ID
Status Completed
Phase Phase 2
First received November 17, 2005
Last updated September 28, 2006
Start date January 2006
Est. completion date September 2006

Study information

Verified date August 2006
Source Urigen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Alkalinized Lidocaine-Heparin


Locations

Country Name City State
United States Georgia Urology Cartersville Georgia
United States St. Mary's Good Samaritan Centralia Illinois
United States The Urology Center Greensboro North Carolina
United States Mid-Michigan Health Centers Jackson Michigan
United States Central Park Urology New York City New York
United States The Urogynecology Center Overland Park Kansas
United States Whitmore Urology Office Philadelphia Pennsylvania
United States UCSD Medical Center San Diego California
United States Urologic Specialists of Oklahoma, Inc. Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Urigen

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall improvement in combined symptoms of pain and urgency at 3 weeks
Secondary Safety
Secondary Reduction in pain on ten point scale at 3 weeks
Secondary Reduction in urgency on ten point scale at 3 weeks
Secondary Change in number of voids/24 hours
Secondary Change in average void volume
Secondary Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
Secondary Reduction in O'Leary-Sant score at 3 weeks
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