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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00921245
First received: June 15, 2009
Last updated: December 19, 2011
Last verified: December 2011
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 83
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921245

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

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00921245     History of Changes
Other Study ID Numbers: 13027, EX0710ZA
Study First Received: June 15, 2009
Last Updated: December 19, 2011
Health Authority: South Africa: Department of Health

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 July 29, 2014