Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003990

Trial Description

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Title

Post-Marketing Surveillance Study Emselex

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

- Data are obtained of Emselex in routine treatment of Overactive Bladder. The general
objectives are to evaluate the product safety, compatibility, efficacy and patient
acceptance.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003990
  •   2012/06/18
  •   2008/11/05
  •   no
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Secondary IDs

  •   NCT00786448  (ClinicalTrials.gov)
  •   12245  (Bayer)
  •   EX0501DE 
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Health Condition or Problem studied

  •   Overactive Bladder
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Drug: Darifenacin, Emselex (BAY79-4998)
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   IV
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Primary Outcome

- Adverse events, Adverse drug reactions, physician's global assessment of tolerability; time frame: After 2-3 months of treatment (long-term 6 months)

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Secondary Outcome

- Incontinence; time frame: At end of study
- Urgency episodes; time frame: At end of study
- Micturitions / nycturitions; time frame: At end of study
- Physician's assessment of improvement/efficacy; time frame: At end of study
- Physician's assessment of patient's satisfaction with therapeutic effect; time frame: At end of study
- Physician's assessment of patient's ability to hold urine; time frame: At end of study
- Dose and treatment duration of Emselex; time frame: At end of study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2005/01/31
  •   5821
  •   Multicenter trial
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Inclusion Criteria

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

- Patients who are treated with Emselex for Overactive Bladder

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Exclusion Criteria

- Exclusion criteria are the contraindications as specified in the German product
information

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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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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Status

  •   Recruiting complete, follow-up complete
  •   2006/02/01
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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 .
  •   6
  •   2016/01/14


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