check_circleStudy Completed

Overactive Bladder

Bayer Identifier:

13027

ClinicalTrials.gov Identifier:

NCT00921245

EudraCT Number:

Not Available

EU CT Number:

Not Available
FREEDOM - First Real-Life Evaluation of Enablex Done in ZA Overactive Bladder patients during a 3 Months period

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

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

Trial summary

Enrollment Goal
9
Trial Dates
June 2007 - February 2009
Phase
N/A
Could I Receive a placebo
No
Products
Emselex (Darifenacin, BAY79-4998)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, South Africa

Primary Outcome

  • To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.
    date_rangeTime Frame:
    3 months later
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • 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
    date_rangeTime Frame:
    3 months later
    enhanced_encryption
    Safety Issue:
    yes

Trial design

First REal-life Evaluation of Darifenacin in Overactive bladder patients during 3 months
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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