Study of U101 for Bladder Pain and/or Urgency

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pelvic Pain, Interstitial Cystitis, Bladder Diseases

Intervention / Treatment
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* Drug: Alkalinized Lidocaine-Heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alkalinized Lidocaine-Heparin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement in combined symptoms of pain and urgency at 3 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial cystitis, pelvic pain, urgency, frequency, Pelvic Pain and/or Urgency of Bladder Origin