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CompletedNCT00171145Updated Jan 23, 2008

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

A Phase 3 interventional study of Darifenacin and Placebo in Overactive Bladder Syndrome, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-23.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
445
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overactive Bladder Syndrome

Keywords

  • Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 445 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
445 participants (actual)

Study arms

  • Experimental
    1

    Darifenacin

    Drug: Darifenacin

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugDarifenacin

    Darifenacin 15 mg tablets once daily

    Also known as: Enablex

  • DrugPlacebo

    Placebo tablets once daily

06

What researchers measure

Primary outcomes

  1. Change from baseline in warning time at week 12.

Secondary outcomes

  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.

07

Study locations

1 site
  • Novartis
    East Hanover, New Jersey 07936-108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00171145
Lead sponsor
Novartis
First posted
Sep 15, 2005
Start date
Apr 2004
Completion
Dec 2004
Last update
Jan 23, 2008

Study contacts

Novartis
study chair · East Hanover NJ
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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