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

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: NCT00921245
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : April 20, 2015
Information provided by:

Brief Summary:
Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin

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

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: First REal-life Evaluation of Darifenacin in Overactive Bladder Patients During 3 Months
Study Start Date : June 2007
Primary Completion Date : October 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Darifenacin (Emselex, BAY79-4998)
Patients in daily clinical treatment receiving Emselex according to local drug information

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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

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.

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): NCT00921245

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

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG Identifier: NCT00921245     History of Changes
Other Study ID Numbers: 13027
EX0710ZA ( Other Identifier: Company internal )
First Posted: June 16, 2009    Key Record Dates
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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents