Post Marketing Surveillance Study on Emselex After Launch in Germany

April 29, 2010 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from routine practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Darifenacin, Emselex (BAY79-4998)
Patients from routine practice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

February 1, 2006

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (ESTIMATE)

November 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 29, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12245
  • EX0501DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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