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Post Marketing Surveillance Study on Emselex After Launch in Germany

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00786448
First received: November 5, 2008
Last updated: April 29, 2010
Last verified: April 2010
History of Changes
  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:

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incontinence [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Urgency episodes [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Micturitions / nycturitions [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Physician's assessment of improvement/efficacy [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Physician's assessment of patient's satisfaction with therapeutic effect [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Physician's assessment of patient's ability to hold urine [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Dose and treatment duration of Emselex [ Time Frame: At end of study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786448

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00786448     History of Changes
Other Study ID Numbers: 12245, EX0501DE
Study First Received: November 5, 2008
Last Updated: April 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Overactive Bladder

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

ClinicalTrials.gov processed this record on June 18, 2013