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Sponsored by: |
Urigen |
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Information provided by: | Urigen |
ClinicalTrials.gov Identifier: | NCT00256542 |
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.
Condition | Intervention | Phase |
---|---|---|
Pelvic Pain Interstitial Cystitis Bladder Diseases |
Drug: Alkalinized Lidocaine-Heparin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 90 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Medical Center | |
San Diego, California, United States, 92103 | |
United States, Georgia | |
Georgia Urology | |
Cartersville, Georgia, United States, 30120 | |
United States, Illinois | |
St. Mary's Good Samaritan | |
Centralia, Illinois, United States, 62801 | |
United States, Kansas | |
The Urogynecology Center | |
Overland Park, Kansas, United States, 66215 | |
United States, Michigan | |
Mid-Michigan Health Centers | |
Jackson, Michigan, United States, 49201 | |
United States, New York | |
Central Park Urology | |
New York City, New York, United States, 10019 | |
United States, North Carolina | |
The Urology Center | |
Greensboro, North Carolina, United States, 27403 | |
United States, Oklahoma | |
Urologic Specialists of Oklahoma, Inc. | |
Tulsa, Oklahoma, United States, 74146 | |
United States, Pennsylvania | |
Whitmore Urology Office | |
Philadelphia, Pennsylvania, United States, 19146 |
Principal Investigator: | C. Lowell Parsons, MD | UCSD |
Study ID Numbers: | URG-101 |
Study First Received: | November 17, 2005 |
Last Updated: | September 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00256542 History of Changes |
Health Authority: | United States: Food and Drug Administration |
interstitial cystitis pelvic pain urgency frequency Pelvic Pain and/or Urgency of Bladder Origin |
Anticoagulants Cystocele Urinary Bladder Diseases Lidocaine Central Nervous System Depressants Anesthetics Cystitis Pain Fibrinolytic Agents Cardiovascular Agents |
Anesthetics, Local Calcium heparin Signs and Symptoms Cystitis, Interstitial Fibrin Modulating Agents Pelvic Pain Urologic Diseases Anti-Arrhythmia Agents Peripheral Nervous System Agents Heparin |
Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Anesthetics Fibrinolytic Agents Pain Signs and Symptoms Fibrin Modulating Agents Urologic Diseases Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Heparin |
Cystocele Anticoagulants Urinary Bladder Diseases Lidocaine Cystitis Central Nervous System Depressants Cardiovascular Agents Pharmacologic Actions Anesthetics, Local Cystitis, Interstitial Pelvic Pain Peripheral Nervous System Agents Central Nervous System Agents |