Status:
TERMINATED
Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis
Overactive Detrusor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00845338
Start Date
February 1 2007
End Date
October 1 2007
Last Update
December 2 2014
Active Locations (15)
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1
Emmendingen, Baden-Wurttemberg, Germany, 79312
2
Heidelberg, Baden-Wurttemberg, Germany, 69112
3
Lahr, Baden-Wurttemberg, Germany, 77933
4
Tübingen, Baden-Wurttemberg, Germany, 72076