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

Overactive Bladder Clinical Trial

— FREEDOM  

Official title:

First REal-life Evaluation of Darifenacin in Overactive Bladder Patients During 3 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921245
• Other study ID #: 13027
• Secondary ID: EX0710ZA
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: April 17, 2015
• Start date: June 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Darifenacin (Emselex, BAY79-4998)
Patients in daily clinical treatment receiving Emselex according to local drug information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.		3 months later	Yes
Secondary	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		3 months later	Yes

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