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FREEDOM - First Real-Life Evaluation of Enablex Done in ZA Overactive Bladder Patients During a 3 Months Period (FREEDOM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921245
First Posted: June 16, 2009
Last Update Posted: April 20, 2015
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
Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: First REal-life Evaluation of Darifenacin in Overactive Bladder Patients During 3 Months

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome. [ Time Frame: 3 months later ]

Secondary Outcome Measures:
  • To evaluate the patient's perception of bladder condition, the patient's use of the patient support program, the patient's and physician's assessment of treatment regarding efficacy and tolerability and patient's compliance with the treatment [ Time Frame: 3 months later ]

Enrollment: 9
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Darifenacin (Emselex, BAY79-4998)
Patients in daily clinical treatment receiving Emselex according to local drug information

  Eligibility

Information from the National Library of Medicine

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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
Private Practice Patients
Criteria

Inclusion Criteria:

  • Male and female patients > 18 years with symptoms of overactive bladder.

Exclusion Criteria:

  • Contraindications for the treatment with Darifenacin prolonged-release tablets according to the registered package insert.
  • Pregnancy and lactation. Women of childbearing potential have to use an acceptable method of contraception.
  • Concomitant treatment with drugs known to affect mainly the urinary bladder function (e.g. anticholinergics, antispasmodics) at any time during the study. Concomitant treatment with botulinum toxin, capsaicin or resiniferatoxin at any time during the study and treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 1.
  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): NCT00921245


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

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00921245     History of Changes
Other Study ID Numbers: 13027
EX0710ZA ( Other Identifier: Company internal )
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: April 20, 2015
Last Verified: April 2015

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