NCT00256542CompletedPhase 2
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
Urigen18 sites in 1 country90 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 18
- Primary Endpoint
- Overall improvement in combined symptoms of pain and urgency at 3 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall improvement in combined symptoms of pain and urgency at 3 weeks
Secondary Outcomes
- Safety
- Reduction in pain on ten point scale at 3 weeks
- Reduction in urgency on ten point scale at 3 weeks
- Change in number of voids/24 hours
- Change in average void volume
- Reduction in PUF score (pelvic pain, urgency/frequency) at 3 weeks
- Reduction in O'Leary-Sant score at 3 weeks
Investigators
Study Sites (18)
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