Study of U101 for Bladder Pain and/or Urgency

NCT ID: NCT00256542

Last Updated: 2006-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-09-30

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.

Conditions

Pelvic Pain; Interstitial Cystitis; Bladder Diseases

Keywords

interstitial cystitis; pelvic pain; urgency; frequency; Pelvic Pain and/or Urgency of Bladder Origin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Alkalinized Lidocaine-Heparin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Urigen

INDUSTRY

Sponsor Role: lead

Principal Investigators

C. Lowell Parsons, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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

Countries

United States

References

Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8. doi: 10.1016/j.urology.2004.08.056.

Reference Type: BACKGROUND

PMID: 15667861 (View on PubMed)

Other Identifiers

URG-101

Identifier Type: -

Identifier Source: org_study_id