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

Primary Purpose

Overactive Bladder, Neurogenic Detrusor Overactivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fesoterodine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Study of fesoterodine in pediatric overactive bladder patients

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fesoterodine once daily

Arm Description

Outcomes

Primary Outcome Measures

Absorption Rate Constant (Ka)
Apparent Volume of Distribution (VC/F)
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.
Area Under the Plasma Drug Concentration Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)
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.

Secondary Outcome Measures

Post-void Residual (PVR) Volume
Volume of urine remaining in the bladder immediately after urination.

Full Information

First Posted
February 26, 2009
Last Updated
November 20, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00857896
Brief Title
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Official Title
An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Neurogenic Detrusor Overactivity
Keywords
Study of fesoterodine in pediatric overactive bladder patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fesoterodine once daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Intervention Description
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
Primary Outcome Measure Information:
Title
Absorption Rate Constant (Ka)
Time Frame
Day 28 and Day 56
Title
Apparent Volume of Distribution (VC/F)
Description
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.
Time Frame
Day 28 and Day 56
Title
Area Under the Plasma Drug Concentration Time Curve (AUC)
Description
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time Frame
Day 28 and Day 56
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Day 28 and Day 56
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
Day 28 and Day 56
Title
Plasma Decay Half-Life (t1/2)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Day 28 and Day 56
Title
Apparent Oral Clearance (CL/F)
Description
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.
Time Frame
Day 28 and Day 56
Secondary Outcome Measure Information:
Title
Post-void Residual (PVR) Volume
Description
Volume of urine remaining in the bladder immediately after urination.
Time Frame
Baseline, Week 4, and Week 8 post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106-8150
Country
United States
Facility Name
Pfizer Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Liberty Township
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221066&StudyName=Study%20Of%20Fesoterodine%20In%20Pediatric%20Overactive%20Bladder%20Patients%20Aged%208-17%20Years
Description
To obtain contact information for a study center near you, click here.

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

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