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

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00845338
First received: February 16, 2009
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention Phase
Multiple Sclerosis
Overactive Detrusor
 Drug: Darifenacin (BAY79-4998)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change from baseline in volume at first detrusor contraction as determined by urodynamics [ Time Frame: At week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Darifenacin (BAY79-4998)
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845338

Locations
Germany
Emmendingen, Baden-Württemberg, Germany, 79312
Heidelberg, Baden-Württemberg, Germany, 69112
Lahr, Baden-Württemberg, Germany, 77933
Tübingen, Baden-Württemberg, Germany, 72076
Villingen-Schwenningen, Baden-Württemberg, Germany, 78054
Planegg, Bayern, Germany, 82152
Oberursel, Hessen, Germany, 61440
Herne, Nordrhein-Westfalen, Germany, 44627
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Mülheim, Nordrhein-Westfalen, Germany, 45468
Mainz, Rheinland-Pfalz, Germany, 55131
Halle, Sachsen-Anhalt, Germany, 06112
Bad Berka, Thüringen, Germany, 99437
Berlin, Germany, 10115
Hamburg, Germany, 20246
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG, Consumer Care
ClinicalTrials.gov Identifier: NCT00845338     History of Changes
Other Study ID Numbers: 12331, 2006-002361-39
Study First Received: February 16, 2009
Last Updated: November 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Darifenacin
Multiple Sclerosis
Open Label Study

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Urinary Bladder, Overactive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Urinary Bladder Diseases
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013