Trial Condition(s):

Overactive Bladder

FREEDOM - First Real-Life Evaluation of Enablex Done in ZA Overactive Bladder patients during a 3 Months period (FREEDOM)

Bayer Identifier:

13027

ClinicalTrials.gov Identifier:

NCT00921245

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal

Trial Dates

June2007

February2009

Phase

N/A

Could I receive a placebo?

Products

Emselex (Darifenacin, BAY79-4998)

Accepts Healthy Volunteers

Where to Participate

Locations

Locations
Locations Investigative Site Many Locations, South Africa	Contact Us: E-mail: [email protected] Phone: Not Available

Investigative Site

Many Locations, South Africa

Contact Us:

E-mail: [email protected]

Phone: Not Available

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:

Primary Outcome

To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.
Timeframe: 3 months later

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
Timeframe: 3 months later

Overactive Bladder

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information