Study of U101 for Bladder Pain and/or Urgency

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Urigen
• Treatments: Calcium heparin; Heparin; Lidocaine

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