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

This study has been terminated.
(The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.)
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00845338
First received: February 16, 2009
Last updated: November 20, 2013
Last verified: November 2013

February 16, 2009
November 20, 2013
February 2007
October 2007   (final data collection date for primary outcome measure)
Change from baseline in volume at first detrusor contraction as determined by urodynamics [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00845338 on ClinicalTrials.gov Archive Site
  • Detrusor pressure at first contraction [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • Volume at first detectable leakage [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • Volume at 10/20/30/40 cm H2O [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • Maximum cystometric bladder capacity [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
  • 7-day micturition diary: Micturitions [ Time Frame: At days 0, 14, 28 ] [ Designated as safety issue: No ]
  • 7-day micturition diary: Urgency episodes [ Time Frame: At days 0, 14, 28 ] [ Designated as safety issue: No ]
  • 7-day micturition diary: Urge urinary incontinence episodes [ Time Frame: At days 0, 14, 28 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity
A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Overactive Detrusor
Drug: Darifenacin (BAY79-4998)
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days
Experimental: Arm 1
Intervention: Drug: Darifenacin (BAY79-4998)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00845338
12331, 2006-002361-39
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP