Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

Phase 2

Terminated

• Conditions: Overactive Detrusor; Multiple Sclerosis
• Interventions: Drug: Darifenacin (BAY79-4998)

• Registration Number: NCT00845338
• Lead Sponsor: Bayer

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-28
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Darifenacin (BAY79-4998)	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in volume at first detrusor contraction as determined by urodynamics	At week 4

Secondary Outcome Measures

Name	Time	Method
Compliance	At week 4
Detrusor pressure at first contraction	At week 4
Volume at first detectable leakage	At week 4
Volume at 10/20/30/40 cm H2O	At week 4
Maximum cystometric bladder capacity	At week 4
7-day micturition diary: Micturitions	At days 0, 14, 28
7-day micturition diary: Urgency episodes	At days 0, 14, 28
7-day micturition diary: Urge urinary incontinence episodes	At days 0, 14, 28