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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00171145
Collaborator
(none)
445
Enrollment
1
Location
2
Arms
8
Duration (Months)
55.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Apr 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Darifenacin

Drug: Darifenacin
Darifenacin 15 mg tablets once daily
Other Names:
  • Enablex

    		•
    Placebo Comparator: 2

    Placebo

    Drug: Placebo
    Placebo tablets once daily

    Outcome Measures

    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. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis East Hanover New Jersey United States 07936-108

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Chair: Novartis, East Hanover NJ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00171145
    Other Study ID Numbers:
    • CDAR328A2401
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Jan 23, 2008
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Darifenacin

    Study Results

    No Results Posted as of Jan 23, 2008