Status:
COMPLETED
Study of U101 for Bladder Pain and/or Urgency
Lead Sponsor:
Urigen
Conditions:
Pelvic Pain
Interstitial Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00256542
Start Date
January 1 2006
End Date
September 1 2006
Last Update
September 29 2006
Active Locations (9)
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1
UCSD Medical Center
San Diego, California, United States, 92103
2
Georgia Urology
Cartersville, Georgia, United States, 30120
3
St. Mary's Good Samaritan
Centralia, Illinois, United States, 62801
4
The Urogynecology Center
Overland Park, Kansas, United States, 66215