Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010336

Trial Description

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Title

Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA for the
treatment of urinary incontinence due to neurogenic detrusor overactivity in patients who
successfully completed Study 191622-120.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00010336
  •   2017/04/27
  •   2013/05/09
  •   no
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Secondary IDs

  •   NCT01852058  (ClinicalTrials.gov)
  •   191622-121  (Allergan)
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Health Condition or Problem studied

  •   Urinary Incontinence
  •   R32 -  Unspecified urinary incontinence
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Interventions/Observational Groups

  •   Biological: OnabotulinumtoxinA
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
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  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Change from Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes; time frame: Baseline, 60 Weeks

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Secondary Outcome

- Change from Baseline in Average Urine Volume at First Morning Catheterization; time frame: Baseline, 60 Weeks
- Percentage of Patients With Night Time Urinary Incontinence; time frame: 60 Weeks
- Time to Patient Request for Retreatment; time frame: 48 Weeks
- Time to Patient Qualification for Retreatment; time frame: 48 Weeks

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Poland
  •   Turkey
  •   United States
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/01/31
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   19   Years
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Additional Inclusion Criteria

- Successfully completed participation in Study 191622-120

- Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120

- Regularly using clean intermittent catheterization to empty the bladder

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Exclusion Criteria

- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

- Current or planned use of a baclofen pump

- Current or planned use of an electrostimulation/neuromodulation device for urinary
incontinence

- Use of an indwelling catheter for urinary incontinence instead of using clean
intermittent catheterization to empty the bladder

- Previous or current use of botulinum toxin therapy of any serotype for any urological
condition, or treatment with botulinum toxin of any serotype for any other condition
since entering study 191622-120

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Addresses

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    • Allergan
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    • Allergan
    • Medical Director 
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    • Clinical Trials Registry Team 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2017/02/20


* This entry means the parameter is not applicable or has not been set.