stop_circleTerminated/Withdrawn
Multiple Sclerosis, Overactive Detrusor
Bayer Identifier:
12331
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 YearsTrial summary
Enrollment Goal
7Trial Dates
February 2007 - October 2007Phase
Phase 2Could I Receive a placebo
NoProducts
Emselex (Darifenacin, BAY79-4998)Accepts Healthy Volunteer
NoWhere 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 urodynamicsdate_rangeTime Frame:At week 4enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Detrusor pressure at first contractiondate_rangeTime Frame:At week 4enhanced_encryptionnoSafety Issue:
- Volume at first detectable leakagedate_rangeTime Frame:At week 4enhanced_encryptionnoSafety Issue:
- Volume at 10/20/30/40 cm H2Odate_rangeTime Frame:At week 4enhanced_encryptionnoSafety Issue:
- Compliancedate_rangeTime Frame:At week 4enhanced_encryptionNoSafety Issue:
- Maximum cystometric bladder capacitydate_rangeTime Frame:At week 4enhanced_encryptionnoSafety Issue:
- 7-day micturition diary: Micturitionsdate_rangeTime Frame:At days 0, 14, 28enhanced_encryptionnoSafety Issue:
- 7-day micturition diary: Urgency episodesdate_rangeTime Frame:At days 0, 14, 28enhanced_encryptionnoSafety Issue:
- 7-day micturition diary: Urge urinary incontinence episodesdate_rangeTime Frame:At days 0, 14, 28enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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