Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease (URGE-PD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT01018264
First received: November 19, 2009
Last updated: June 27, 2014
Last verified: June 2014

November 19, 2009
June 27, 2014
January 2010
August 2014   (final data collection date for primary outcome measure)
The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018264 on ClinicalTrials.gov Archive Site
  • To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To examine the effect of solifenacin succinate (VESIcare) on quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease
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

This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder in Parkinson's Disease
  • Drug: solifenacin succinate (VESIcare)
    up to 10mg every day orally
  • Drug: placebo
    placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
  • Experimental: solifenacin succinate (VESIcare)
    Intervention: Drug: solifenacin succinate (VESIcare)
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
August 2014
August 2014   (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 40 years to 80 years.
  3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
  4. Patients must score 1.0 to 3.0 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 overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months.
  7. The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician).
  8. The patient must have had a bladder scan within six months of the screening visit. This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline.
  9. Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 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 scores less than 27).
  5. Legal incapacity or limited legal capacity.
  6. History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
  7. Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit.
  8. Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
  9. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
  10. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
  11. History of narrow angle glaucoma.
  12. Patients who have undergone pelvic radiation at any time.
  13. Currently taking any of the following medications:

    • Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps)
    • Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril)
    • Tricyclic anti-depressants: amitriptyline (Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl), amoxapine (Asendin, Asendis, Defanyl, Demolox, Moxadil), clomipramine (Anafranil), desipramine (Norpramin, Pertofrane), imipramine (Antideprin, Deprenil, Deprimin, Deprinol, Depsonil, Dynaprin, Eupramin, Imipramil, Irmin, Janimine, Melipramin, Surplix, Tofranil), nortriptyline (Aventyl, Pamelor, Nortrilen), protriptyline (Vivactil), trimipramine (Stangyl, Surmontil, Rhotrimine)
    • Psychotropics: doxepin (Aponal, Adapine, Sinquan, Sinequan)
    • Anticholinergics/Antispasmodics: trihexyphenidyl (Artane, Aparkan), benztropine (Cogentin), oxybutynin (Ditropan, Ditropan XL, Lyrinel XL, Oxytrol), darifenacin (Enablex), emepronium, flavoxate (Urispas), meladrazine, propiverine, solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), trospium (Sanctura)
    • Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI): duloxetine (Cymbalta, Yentreve), Venlafaxine (Effexor, Effexor XR)
    • Arylalkylamines: pseudoephedrine (Sudafed)
    • Anti-androgen: bicalutamide (Casodex, Cosudex, Calutide, Kalumid), finasteride (Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX), dutasteride (Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost), Zoladex (goserelin acetate), Eulexin (flutamide), Lupron (leuprolide acetate)
    • Antihypertensives: prazosin (Minipress, Vasoflex, Hypovase)
    • Estrogens (Menest, Premarin, Premarin IV)
    • Acetylcholinesterase inhibitors (rivastigmine (Exelon), galantamine, (Reminyl, donepezil (Aricept), Tacrine.
    • Memantine (Namenda)
  14. Urinary obstruction in male PD patients as diagnosed by a urologist
  15. Active urinary tract infection.
  16. Patients with a history of chronic severe constipation (by self report)
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018264
Sullivan-9
No
Theresa Zesiewicz, University of South Florida
University of South Florida
Astellas Pharma Inc
Principal Investigator: Theresa Zesiewicz, MD University of South Florida
Principal Investigator: Marian Evatt, MD Emory University
Principal Investigator: Carlos Singer, MD University of Miami
University of South Florida
June 2014

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