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

NCT ID: NCT00921245

Last Updated: 2015-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Darifenacin (Emselex, BAY79-4998)

Intervention Type DRUG

Patients in daily clinical treatment receiving Emselex according to local drug information

Interventions

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Darifenacin (Emselex, BAY79-4998)

Patients in daily clinical treatment receiving Emselex according to local drug information

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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EX0710ZA

Identifier Type: OTHER

Identifier Source: secondary_id

13027

Identifier Type: -

Identifier Source: org_study_id

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