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Post Marketing Surveillance Study on Emselex After Launch in Germany

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00786448
First Posted: November 6, 2008
Last Update Posted: April 30, 2010
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.
Information provided by:
Bayer
  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.

Condition Intervention Phase
Overactive Bladder Drug: Darifenacin, Emselex (BAY79-4998) Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Study Emselex

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 5821
Study Start Date: January 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Darifenacin, Emselex (BAY79-4998)
Patients from routine practice

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00786448


Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00786448     History of Changes
Other Study ID Numbers: 12245
EX0501DE
First Submitted: November 5, 2008
First Posted: November 6, 2008
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
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents