Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

November 20, 2011 updated by: Pfizer

An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.

The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Pfizer Investigational Site
    • California
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106-8150
        • Pfizer Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48084
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Liberty Township, Ohio, United States, 45044
        • Pfizer Investigational Site

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

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A total body weight >25 kg (55 lbs).
  • Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
  • Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.

Exclusion Criteria:

  • Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
  • Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
  • Ongoing use of another drug for treating overactive bladder
  • Uncontrolled narrow angle glaucoma, urinary or gastric retention

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fesoterodine once daily
Drug: Fesoterodine
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absorption Rate Constant (Ka)
Time Frame: Day 28 and Day 56
Day 28 and Day 56
Apparent Volume of Distribution (VC/F)
Time Frame: Day 28 and Day 56
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.
Day 28 and Day 56
Area Under the Plasma Drug Concentration Time Curve (AUC)
Time Frame: Day 28 and Day 56
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Day 28 and Day 56
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 28 and Day 56
Day 28 and Day 56
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 28 and Day 56
Day 28 and Day 56
Plasma Decay Half-Life (t1/2)
Time Frame: Day 28 and Day 56
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Day 28 and Day 56
Apparent Oral Clearance (CL/F)
Time Frame: Day 28 and Day 56
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Day 28 and Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-void Residual (PVR) Volume
Time Frame: Baseline, Week 4, and Week 8 post-dose
Volume of urine remaining in the bladder immediately after urination.
Baseline, Week 4, and Week 8 post-dose

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 20, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221066

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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