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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 12, 2005
Last updated: January 18, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Overactive Bladder Syndrome
Drug: Darifenacin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in warning time at week 12.

Secondary Outcome Measures:
  • Change in warning time at weeks 2 & 6.
  • Change in frequency of urge incontinence episodes.
  • Change in frequency of micturitions.
  • Change in mean volume per void.
  • Change in frequency of urgency.
  • Safety and tolerability.
  • Quality of life.

Enrollment: 445
Study Start Date: April 2004
Study Completion Date: December 2004
Arms Assigned Interventions
Experimental: 1
Drug: Darifenacin
Darifenacin 15 mg tablets once daily
Other Name: Enablex
Placebo Comparator: 2
Drug: Placebo
Placebo tablets once daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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.

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Please refer to this study by its identifier: NCT00171145

United States, New Jersey
East Hanover, New Jersey, United States, 07936-108
Sponsors and Collaborators
Study Chair: Novartis East Hanover NJ
  More Information

Responsible Party: External Affairs, Novartis Identifier: NCT00171145     History of Changes
Other Study ID Numbers: CDAR328A2401
Study First Received: September 12, 2005
Last Updated: January 18, 2008

Keywords provided by Novartis:
Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on April 27, 2017