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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00857896
First received: February 26, 2009
Last updated: November 20, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Neurogenic Detrusor Overactivity
Drug: Fesoterodine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Absorption Rate Constant (Ka) [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution (VC/F) [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
    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 Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Apparent Oral Clearance (CL/F) [ Time Frame: Day 28 and Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 4, and Week 8 post-dose ] [ Designated as safety issue: No ]
    Volume of urine remaining in the bladder immediately after urination.


Enrollment: 21
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine once daily Drug: Fesoterodine
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857896

Locations
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72204
United States, California
Pfizer Investigational Site
Long Beach, California, United States, 90806
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71106-8150
United States, Michigan
Pfizer Investigational Site
Troy, Michigan, United States, 48084
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45229
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Liberty Township, Ohio, United States, 45044
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00857896     History of Changes
Other Study ID Numbers: A0221066
Study First Received: February 26, 2009
Results First Received: October 4, 2011
Last Updated: November 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Study of fesoterodine in pediatric overactive bladder patients

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014