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Post Marketing Surveillance Study on Emselex After Launch in Germany

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ClinicalTrials.gov Identifier: NCT00786448
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : April 30, 2010
Sponsor:
Information provided by:
Bayer

November 5, 2008
November 6, 2008
April 30, 2010
January 2005
February 2006   (Final data collection date for primary outcome measure)
Adverse events, Adverse drug reactions, physician's global assessment of tolerability [ Time Frame: After 2-3 months of treatment (long-term 6 months) ]
Not Provided
Complete list of historical versions of study NCT00786448 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Post Marketing Surveillance Study on Emselex After Launch in Germany
Post-Marketing Surveillance Study Emselex
- 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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients from routine practice
Overactive Bladder
Drug: Darifenacin, Emselex (BAY79-4998)
Patients from routine practice
Group 1
Intervention: Drug: Darifenacin, Emselex (BAY79-4998)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5821
Same as current
February 2006
February 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are treated with Emselex for Overactive Bladder

Exclusion Criteria:

  • Exclusion criteria are the contraindications as specified in the German product information
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00786448
12245
EX0501DE
No
Not Provided
Not Provided
Medical Director, Bayer Schering Pharma AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2010