Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged

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

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-06-30

Brief Summary

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The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>Ý 65 years with OAB.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet once daily with sham titration

Interventions

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Darifenacin

Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

Intervention Type DRUG

Placebo

Placebo tablet once daily with sham titration

Intervention Type DRUG

Other Intervention Names

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Enablex

Eligibility Criteria

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Inclusion Criteria

* Symptoms of OAB for at least six months prior to Visit 3
* Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
* ≥ 1 UUIE on average per day and
* ≥ 10 episodes of micturition on average per day

Exclusion Criteria

* A total daily urinary volume \> 3000 ml or a mean volume voided per micturition of \> 300 ml as verified in the micturition diary before randomization
* Post-void residual (PVR) urinary volume \> 100 ml
* Clinically significant stress urinary incontinence as determined by the investigator
* Clinically significant bladder outlet obstruction as determined by the investigator
* Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No