NCT00170755

Brief Summary

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
718

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2002

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

First QC Date

September 9, 2005

Last Update Submit

January 15, 2008

Conditions

Overactive Bladder Syndrome

Keywords

Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment

Outcome Measures

Primary Outcomes (1)

  • Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.

Secondary Outcomes (2)

  • Long term efficacy on the symptoms of overactive bladder

  • King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),

Study Arms (1)

1

EXPERIMENTAL

Darifenacin

Drug: Darifenacin

Interventions

DarifenacinDRUG

Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily

Also known as: Enablex
1

Eligibility Criteria

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

You may qualify if:

  • Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
  • 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

Related Publications (1)

  • Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27(6):540-7. doi: 10.1002/nau.20620.

    PMID: 18663723DERIVED

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

April 1, 2002

Study Completion

January 1, 2005

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

US(1)