Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
This study has been withdrawn prior to enrollment.
(Study withdrawn with intent of persuing larger, multi-site study.)
Sponsor:
University of South Florida
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00584090
First received: December 21, 2007
Last updated: November 30, 2012
Last verified: October 2010
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Purpose
The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients.
The secondary objective of this study is to examine the effect of solifenacin succinate (VESIcare) on symptoms of PD and the patient's quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence Parkinson's Disease |
Drug: Solifenacin Succinate (VESIcare) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objective of this study is to examine the effect of solifenacin succinate (VESIcare) on symptoms of PD and the patient's quality of life. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Solifenacin Succinate (VESIcare)
5 - 10 mg po qd for 1 month
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo equivalent of 5-10 mg po qd for 1 month
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
- Age 30 years to 80 years.
- Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
- Patients must score 18 or higher on the UPDRS scale and 1.0 to 2.5 on the Modified Hoehn and Yahr scale.
- Women of child-bearing potential must use a reliable method of contraception.
- Must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
- Patients must have evidence of normal PSA and urodynamic tests within the last 12 months.
- Clearance from the patient's urologist or internist who has examined the patient within the last 12-months.
Exclusion Criteria:
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- Legal incapacity or limited legal capacity.
- Presence of severe renal disease (BUN 50% greater than normal).
- Presence of major hepatic impairment.
- Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor.
- Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
- History of controlled narrow angle glaucoma.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584090
Locations
| United States, Florida | |
| University of South Florida | |
| Tampa, Florida, United States, 33612 | |
Sponsors and Collaborators
University of South Florida
Investigators
| Principal Investigator: | Theresa A Zesiewicz, MD | University of South Florida |
More Information
No publications provided
| Responsible Party: | Theresa Zesiewicz, MD, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00584090 History of Changes |
| Other Study ID Numbers: | 4, 104803b |
| Study First Received: | December 21, 2007 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
urinary incontinence parkinson's disease vesicare solifenacin succinate |
Additional relevant MeSH terms:
|
Parkinson Disease Urinary Incontinence Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Urination Disorders 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 |
ClinicalTrials.gov processed this record on May 19, 2013