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

EU CT Number:

Not Available

Terminated/Withdrawn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
black-arrow
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
Locations
Locations

St. Hedwig Krankenhaus

Berlin, Germany, 10115

Locations

Praxis Dr. A.-D. Marschall-Kehrel

Oberursel, Germany, 61440

Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

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Praxis Dr. Stefan Carl & Dr. Achim Forth

Emmendingen, Germany, 79312

Locations

Urologische Klinik München-Planegg

Planegg, Germany, 82152

Locations

Berufsgenossenschaftl. Kliniken Bergmannstrost

Halle, Germany, 06112

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Klinikum der Stadt Villingen-Schwenningen GmbH

Villingen-Schwenningen, Germany, 78054

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Praxis Dr. S. Laschke

Lahr, Germany, 77933

Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

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Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

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Marienhospital Herne Klinik Börnig

Herne, Germany, 44627

Locations

Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69112

Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Locations

Praxis Drs. Tim Schneider /B. Schneider

Mülheim, Germany, 45468

Trial Design