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A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

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Novartis

Status and phase

Completed
Phase 3

Conditions

Overactive Bladder Syndrome

Treatments

Drug: Placebo
Drug: Darifenacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171145
CDAR328A2401

Details and patient eligibility

About

This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.

Enrollment

445 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
  • 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

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

445 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Darifenacin
Treatment:
Drug: Darifenacin
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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