Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006450

Trial Description

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Title

A Study Evaluating the Efficacy and Safety of Botulinum Toxin Type A and Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A study to evaluate the efficacy and safety of botulinum toxin type A (BOTOX®) in patients
with overactive bladder (OAB) and urinary incontinence.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006450
  •   2015/03/23
  •   2013/01/11
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01767519  (ClinicalTrials.gov)
  •   191622-125  (Allergan)
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Health Condition or Problem studied

  •   Overactive Bladder
  •   Urinary Incontinence
  •   N32.8 -  Other specified disorders of bladder
  •   R32 -  Unspecified urinary incontinence
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Interventions/Observational Groups

  •   Biological: botulinum toxin type A
  •   Drug: solifenacin
  •   Drug: placebo (normal saline)
  •   Drug: solifenacin placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Number of Episodes of Urinary Incontinence; time frame: Week 12
- Percentage of participants who are 100% incontinence-free/dry; time frame: Week 12

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Secondary Outcome

- Percentage of participants with positive response on the single-item Treatment Benefit Scale; time frame: Week 12
- Number of micturition episodes; time frame: Week 12
- Number of Nocturia Episodes; time frame: Week 12
- King's Health Questionnaire Role and Social Limitation Domain Scores; time frame: Week 12

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Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Poland
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/03/31
  •   345
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence
for at least 6 months

- Inadequate response or limiting side effects with anticholinergics for the treatment
of OAB

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Exclusion Criteria

- Overactive Bladder caused by neurological condition

- Patient has predominance of stress incontinence

- Use of anticholinergics or other medications to treat OAB symptoms in the 7 days
prior to screening

- Previous use of solifenacin

- History or evidence of pelvic or urological abnormality

- Previous use of any botulinum toxin of any serotype for any urological condition

- Previous use of any botulinum toxin of any serotype for any non-urological condition
within 12 weeks of randomization

- Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

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Addresses

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    • Allergan
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    • Allergan
    • Medical Director 
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    • Allergan
    • Medical Director 
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    •   [---]*
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    •   [---]*
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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 complete, follow-up complete
  •   2015/03/01
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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 .
  •   2
  •   2015/06/25


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