A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

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

Clinical Phase

PHASE3

Total Enrollment

718 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-01-31

Brief Summary

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This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

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Healthy Volunteers

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Detailed Description

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Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily

Interventions

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Darifenacin

Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily

Intervention Type DRUG

Other Intervention Names

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Enablex

Eligibility Criteria

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Inclusion Criteria

* Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
* Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria

* Patients in whom the use of anticholinergic drugs was contraindicated
* Evidence of severe liver disease
* Patients with other clinically significant urinary or gynecological conditions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No