Post Marketing Surveillance Study on Emselex After Launch in Germany

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786448
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : April 30, 2010
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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.

Condition or disease Intervention/treatment
Overactive Bladder Drug: Darifenacin, Emselex (BAY79-4998)

Study Type : Observational
Actual Enrollment : 5821 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Study Emselex
Study Start Date : January 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Adverse events, Adverse drug reactions, physician's global assessment of tolerability [ Time Frame: After 2-3 months of treatment (long-term 6 months) ]

Secondary Outcome Measures :
  1. Incontinence [ Time Frame: At end of study ]
  2. Urgency episodes [ Time Frame: At end of study ]
  3. Micturitions / nycturitions [ Time Frame: At end of study ]
  4. Physician's assessment of improvement/efficacy [ Time Frame: At end of study ]
  5. Physician's assessment of patient's satisfaction with therapeutic effect [ Time Frame: At end of study ]
  6. Physician's assessment of patient's ability to hold urine [ Time Frame: At end of study ]
  7. Dose and treatment duration of Emselex [ Time Frame: At end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from routine practice

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786448

Many Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Schering Pharma AG Identifier: NCT00786448     History of Changes
Other Study ID Numbers: 12245
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Bayer:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents