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Trial record 1 of 1 for:    NCT00845338
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Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

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ClinicalTrials.gov Identifier: NCT00845338
Recruitment Status : Terminated (The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.)
First Posted : February 18, 2009
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in volume at first detrusor contraction as determined by urodynamics [ Time Frame: At week 4 ]

Secondary Outcome Measures :
  1. Detrusor pressure at first contraction [ Time Frame: At week 4 ]
  2. Volume at first detectable leakage [ Time Frame: At week 4 ]
  3. Volume at 10/20/30/40 cm H2O [ Time Frame: At week 4 ]
  4. Compliance [ Time Frame: At week 4 ]
  5. Maximum cystometric bladder capacity [ Time Frame: At week 4 ]
  6. 7-day micturition diary: Micturitions [ Time Frame: At days 0, 14, 28 ]
  7. 7-day micturition diary: Urgency episodes [ Time Frame: At days 0, 14, 28 ]
  8. 7-day micturition diary: Urge urinary incontinence episodes [ Time Frame: At days 0, 14, 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845338


Locations
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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
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00845338    
Other Study ID Numbers: 12331
2006-002361-39 ( EudraCT Number )
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Bayer:
Darifenacin
Multiple Sclerosis
Open Label Study
Additional relevant MeSH terms:
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Multiple Sclerosis
Urinary Bladder, Overactive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urinary Bladder Diseases
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents