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Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
This study has been withdrawn prior to recruitment.
( Study withdrawn with intent of persuing larger, multi-site study. )
Study NCT00584090   Information provided by University of South Florida
First Received: December 21, 2007   Last Updated: June 2, 2008   History of Changes

December 21, 2007
June 2, 2008
November 2007
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00584090 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
 

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.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Urinary Incontinence
  • Parkinson's Disease
  • Drug: Solifenacin Succinate (VESIcare)
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Withdrawn
30
 
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
  2. Age 30 years to 80 years.
  3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
  4. Patients must score 18 or higher on the UPDRS scale and 1.0 to 2.5 on the Modified Hoehn and Yahr scale.
  5. Women of child-bearing potential must use a reliable method of contraception.
  6. Must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
  7. Patients must have evidence of normal PSA and urodynamic tests within the last 12 months.
  8. Clearance from the patient's urologist or internist who has examined the patient within the last 12-months.

Exclusion Criteria:

  1. Any illness that in the investigator's opinion preclude participation in this study.
  2. Pregnancy or lactation.
  3. Concurrent participation in another clinical study.
  4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
  5. Legal incapacity or limited legal capacity.
  6. Presence of severe renal disease (BUN 50% greater than normal).
  7. Presence of major hepatic impairment.
  8. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor.
  9. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
  10. History of controlled narrow angle glaucoma.
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584090
Theresa Zesiewicz, MD, University of South Florida
4, 104803b
University of South Florida
 
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida
University of South Florida
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP