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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171145
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 23, 2008
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: Darifenacin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : April 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Darifenacin
Darifenacin 15 mg tablets once daily
Other Name: Enablex

Placebo Comparator: 2
Drug: Placebo
Placebo tablets once daily

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171145

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

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Responsible Party: External Affairs, Novartis Identifier: NCT00171145    
Other Study ID Numbers: CDAR328A2401
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 23, 2008
Last Verified: January 2008
Keywords provided by Novartis:
Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
Additional relevant MeSH terms:
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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