check_circleStudy Completed

Overactive Bladder

Bayer Identifier:

12245

ClinicalTrials.gov Identifier:

NCT00786448

EudraCT Number:

Not Available

EU CT Number:

Not Available
Post Marketing Surveillance Study on Emselex after launch in Germany

Trial purpose

- 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients who are treated with Emselex for Overactive Bladder

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

Trial summary

Enrollment Goal
5821
Trial Dates
January 2005 - February 2006
Phase
N/A
Could I Receive a placebo
No
Products
Emselex (Darifenacin, BAY79-4998)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Adverse events, Adverse drug reactions, physician's global assessment of tolerability
    date_rangeTime Frame:
    After 2-3 months of treatment (long-term 6 months)
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    Safety Issue:
    Yes

Secondary Outcome

  • Incontinence
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    no
  • Urgency episodes
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    no
  • Micturitions / nycturitions
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    No
  • Physician's assessment of improvement/efficacy
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    No
  • Physician's assessment of patient's satisfaction with therapeutic effect
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    No
  • Physician's assessment of patient's ability to hold urine
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    No
  • Dose and treatment duration of Emselex
    date_rangeTime Frame:
    At end of study
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    Safety Issue:
    No

Trial design

Post-Marketing Surveillance Study Emselex
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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