Trial Condition(s):
Overactive Bladder
Post Marketing Surveillance Study on Emselex after launch in Germany
Bayer Identifier:
12245
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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
Trial Summary
Enrollment Goal
5821
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Emselex (Darifenacin, BAY79-4998)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Adverse events, Adverse drug reactions, physician's global assessment of tolerabilityTimeframe: After 2-3 months of treatment (long-term 6 months)
Secondary Outcome
- IncontinenceTimeframe: At end of study
- Urgency episodesTimeframe: At end of study
- Micturitions / nycturitionsTimeframe: At end of study
- Physician's assessment of improvement/efficacyTimeframe: At end of study
- Physician's assessment of patient's satisfaction with therapeutic effectTimeframe: At end of study
- Physician's assessment of patient's ability to hold urineTimeframe: At end of study
- Dose and treatment duration of EmselexTimeframe: At end of study
Additional Information
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