Study of U101 for Bladder Pain and/or Urgency

Completed · Phase 2

Conditions studied: Pelvic Pain, Interstitial Cystitis, Bladder Diseases

In brief

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.

Key facts

Study ID: NCT00256542
Run by: Urigen
People needed: 90
Starts: 2006-01-01
Expected to finish: 2006-09-01
Last updated by the study team: 2006-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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