Trial Condition(s):

Multiple Sclerosis, Overactive Detrusor

Study of darifenacin in patients suffering from multiple sclerosis and neurogenic detrusor overactivity

Bayer Identifier:

12331

ClinicalTrials.gov Identifier:

NCT00845338

EudraCT Number:

2006-002361-39

Terminated/Withdrawn

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.

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 </= 35,0 kg/qm
- 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 Exclusion Criteria

Trial Summary

Enrollment Goal
7
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Emselex (Darifenacin, BAY79-4998)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

St. Hedwig Krankenhaus

Berlin, Germany, 10115

Status
Terminated
 
Locations

Praxis Dr. A.-D. Marschall-Kehrel

Oberursel, Germany, 61440

Status
Terminated
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Praxis Dr. Stefan Carl & Dr. Achim Forth

Emmendingen, Germany, 79312

Status
Completed
 
Locations

Urologische Klinik München-Planegg

Planegg, Germany, 82152

Status
Completed
 
Locations

Berufsgenossenschaftl. Kliniken Bergmannstrost

Halle, Germany, 06112

Status
Terminated
 
Locations

Klinikum der Stadt Villingen-Schwenningen GmbH

Villingen-Schwenningen, Germany, 78054

Status
Terminated
 
Locations

Praxis Dr. S. Laschke

Lahr, Germany, 77933

Status
Terminated
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Terminated
 
Locations

Marienhospital Herne Klinik Börnig

Herne, Germany, 44627

Status
Terminated
 
Locations

Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

Status
Terminated
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69112

Status
Terminated
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Terminated
 
Locations

Praxis Drs. Tim Schneider /B. Schneider

Mülheim, Germany, 45468

Status
Completed
 

Trial Design