NCT00171145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 23, 2008

Status Verified

January 1, 2008

First QC Date

September 12, 2005

Last Update Submit

January 18, 2008

Conditions

Overactive Bladder Syndrome

Keywords

Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in warning time at week 12.

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Darifenacin

Drug: Darifenacin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DarifenacinDRUG

Darifenacin 15 mg tablets once daily

Also known as: Enablex
1
PlaceboDRUG

Placebo tablets once daily

2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients in whom the use of anticholinergic drugs was contraindicated
  • Evidence of severe liver disease
  • Patients with other clinically significant urinary or gynecological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936-108, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

darifenacin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis

    East Hanover NJ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2004

Study Completion

December 1, 2004

Last Updated

January 23, 2008

Record last verified: 2008-01

Locations

US(1)