Terminated/Withdrawn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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Dates

February 2007 - October 2007

Phase

Phase 2

Could I Receive a placebo

Products

Emselex (Darifenacin, BAY79-4998)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	St. Hedwig Krankenhaus	Berlin, 10115, Germany
Terminated	Praxis Dr. A.-D. Marschall-Kehrel	Oberursel, 61440, Germany
Completed	Kliniken Maria Hilf GmbH	Mönchengladbach, 41063, Germany
Completed	Praxis Dr. Stefan Carl & Dr. Achim Forth	Emmendingen, 79312, Germany
Completed	Urologische Klinik München-Planegg	Planegg, 82152, Germany
Terminated	Berufsgenossenschaftl. Kliniken Bergmannstrost	Halle, 06112, Germany
Terminated	Klinikum der Stadt Villingen-Schwenningen GmbH	Villingen-Schwenningen, 78054, Germany
Terminated	Praxis Dr. S. Laschke	Lahr, 77933, Germany
Completed	Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg, 20246, Germany
Terminated	Johannes-Gutenberg-Universität Mainz	Mainz, 55131, Germany
Terminated	Marienhospital Herne Klinik Börnig	Herne, 44627, Germany
Terminated	Zentralklinik Bad Berka GmbH	Bad Berka, 99437, Germany
Terminated	Universitätsklinikum Heidelberg	Heidelberg, 69112, Germany
Terminated	Klinikum der Eberhard-Karls-Universität Tübingen	Tübingen, 72076, Germany
Completed	Praxis Drs. Tim Schneider /B. Schneider	Mülheim, 45468, Germany

Primary Outcome

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

Secondary Outcome

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

Additional Information

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