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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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171145
First received: September 12, 2005
Last updated: January 18, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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
Darifenacin
 Drug: Darifenacin
Darifenacin 15 mg tablets once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo tablets once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171145

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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00171145     History of Changes
Other Study ID Numbers: CDAR328A2401
Study First Received: September 12, 2005
Last Updated: January 18, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Darifenacin
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013