Post Marketing Surveillance Study on Emselex After Launch in Germany

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Darifenacin, Emselex (BAY79-4998)

• Registration Number: NCT00786448
• Lead Sponsor: Bayer

Brief Summary

- 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5821

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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Darifenacin, Emselex (BAY79-4998)	-

Primary Outcome Measures

Name	Time	Method
Adverse events, Adverse drug reactions, physician's global assessment of tolerability	After 2-3 months of treatment (long-term 6 months)

Secondary Outcome Measures

Name	Time	Method
Incontinence	At end of study
Urgency episodes	At end of study
Micturitions / nycturitions	At end of study
Physician's assessment of improvement/efficacy	At end of study
Physician's assessment of patient's satisfaction with therapeutic effect	At end of study
Physician's assessment of patient's ability to hold urine	At end of study
Dose and treatment duration of Emselex	At end of study