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Clinical Trials/NCT00845338
NCT00845338TerminatedPhase 2

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

Bayer0 sites7 target enrollmentStarted: February 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Bayer
Enrollment
7
Primary Endpoint
Change from baseline in volume at first detrusor contraction as determined by urodynamics

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Arm 1

Experimental

Intervention: Darifenacin (BAY79-4998) (Drug)

Outcomes

Primary Outcomes

Change from baseline in volume at first detrusor contraction as determined by urodynamics

Time Frame: At week 4

Secondary Outcomes

  • 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)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

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