stop_circleTerminated/Withdrawn

Multiple Sclerosis, Overactive Detrusor

Bayer Identifier:

12331

ClinicalTrials.gov Identifier:

NCT00845338

EudraCT Number:

2006-002361-39

EU CT Number:

Not Available
Study of darifenacin in patients suffering from multiple sclerosis and neurogenic detrusor overactivity

Trial purpose

The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients with multiple sclerosis for at least 6 months
    - Neurogenic detrusor overactivity without DSD
    - Symptoms of OAB
    - Patients capable of completing the bladder diary
    - Patients capable of independent toileting
    - Patients able to swallow the study medication in accordance to the protocol
    - Body Mass Index >/= 18,8 kg/qm and - documented, dated, written informed consent
  • - Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
    - Participation in a bladder-training program
    - Low compliance bladder (Compliance <20 mL/cm H2O)
    - DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
    - Indwelling catheter or intermittent self-catheterization
    - Patience with post-void residual (PVR) urinary volume > 200 mL at baseline
    - Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
    - Clinically predominant and bothersome stress urinary incontinence
    - Neurological diseases other than multiple sclerosis affecting urinary bladder function
    - Any urogenital surgery within 12 month prior to Visit 1
    - 17 Additional

Trial summary

Enrollment Goal
7
Trial Dates
February 2007 - October 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Emselex (Darifenacin, BAY79-4998)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
St. Hedwig KrankenhausBerlin, 10115, Germany
Terminated
Praxis Dr. A.-D. Marschall-KehrelOberursel, 61440, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
Praxis Dr. Stefan Carl & Dr. Achim ForthEmmendingen, 79312, Germany
Completed
Urologische Klinik München-PlaneggPlanegg, 82152, Germany
Terminated
Berufsgenossenschaftl. Kliniken BergmannstrostHalle, 06112, Germany
Terminated
Klinikum der Stadt Villingen-Schwenningen GmbHVillingen-Schwenningen, 78054, Germany
Terminated
Praxis Dr. S. LaschkeLahr, 77933, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Terminated
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Terminated
Marienhospital Herne Klinik BörnigHerne, 44627, Germany
Terminated
Zentralklinik Bad Berka GmbHBad Berka, 99437, Germany
Terminated
Universitätsklinikum HeidelbergHeidelberg, 69112, Germany
Terminated
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Praxis Drs. Tim Schneider /B. SchneiderMülheim, 45468, Germany

Primary Outcome

  • Change from baseline in volume at first detrusor contraction as determined by urodynamics
    date_rangeTime Frame:
    At week 4
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Detrusor pressure at first contraction
    date_rangeTime Frame:
    At week 4
    enhanced_encryption
    Safety Issue:
    no
  • Volume at first detectable leakage
    date_rangeTime Frame:
    At week 4
    enhanced_encryption
    Safety Issue:
    no
  • Volume at 10/20/30/40 cm H2O
    date_rangeTime Frame:
    At week 4
    enhanced_encryption
    Safety Issue:
    no
  • Compliance
    date_rangeTime Frame:
    At week 4
    enhanced_encryption
    Safety Issue:
    No
  • Maximum cystometric bladder capacity
    date_rangeTime Frame:
    At week 4
    enhanced_encryption
    Safety Issue:
    no
  • 7-day micturition diary: Micturitions
    date_rangeTime Frame:
    At days 0, 14, 28
    enhanced_encryption
    Safety Issue:
    no
  • 7-day micturition diary: Urgency episodes
    date_rangeTime Frame:
    At days 0, 14, 28
    enhanced_encryption
    Safety Issue:
    no
  • 7-day micturition diary: Urge urinary incontinence episodes
    date_rangeTime Frame:
    At days 0, 14, 28
    enhanced_encryption
    Safety Issue:
    no

Trial design

A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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