Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

May 16, 2017 updated by: Novartis
The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Scott Department of Urology Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of OAB for at least six months prior to Visit 3
  • Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
  • ≥ 1 UUIE on average per day and
  • ≥ 10 episodes of micturition on average per day

Exclusion Criteria:

  • A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization
  • Post-void residual (PVR) urinary volume > 100 ml
  • Clinically significant stress urinary incontinence as determined by the investigator
  • Clinically significant bladder outlet obstruction as determined by the investigator
  • Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Other protocol inclusion / exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo tablet once daily with sham titration
Experimental: 1
Darifenacin
Drug: Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Names:
  • Enablex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.

Secondary Outcome Measures

Outcome Measure
Safety and tolerability.
Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
Quality of life at week 6 and/or 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Procter and Gamble

Investigators

  • Study Chair: Novartis, East Hanover NJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDAR328A2409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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