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| Sponsor: | University of South Florida |
|---|---|
| Collaborator: |
Astellas Pharma Inc |
| Information provided by: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01018264 |
Purpose
This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder in Parkinson's Disease |
Drug: solifenacin succinate (VESIcare) Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: solifenacin succinate (VESIcare) |
Drug: solifenacin succinate (VESIcare)
up to 10mg every day orally
|
| Placebo Comparator: placebo |
Drug: placebo
placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Currently taking any of the following medications:
Contacts and Locations| Contact: Kelly Sullivan, MSPH | 813-974-5909 | kbarber@health.usf.edu |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Wendy Levy, CCRC 305-243-3530 WLevy@med.miami.edu | |
| Principal Investigator: Carlos Singer, MD | |
| University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Kelly Sullivan, MSPH 813-974-5909 kbarber@health.usf.edu | |
| Principal Investigator: Theresa Zesiewicz, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: Barbara Sommerfeld, MSN, RN 404-728-6944 bsommer@emory.edu | |
| Principal Investigator: Marian Evatt, MD | |
| Principal Investigator: | Theresa Zesiewicz, MD | University of South Florida |
| Principal Investigator: | Marian Evatt, MD | Emory University |
| Principal Investigator: | Carlos Singer, MD | University of Miami |
More Information
| Responsible Party: | Theresa Zesiewicz, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01018264 History of Changes |
| Other Study ID Numbers: | Sullivan-9 |
| Study First Received: | November 19, 2009 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Overactive bladder Urinary incontinence Urinary frequency Parkinson's disease |
|
Parkinson Disease Urinary Bladder, Overactive Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Urinary Bladder Diseases Urologic Diseases |
Urological Manifestations Signs and Symptoms Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |