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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00857896
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : November 17, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Neurogenic Detrusor Overactivity Drug: Fesoterodine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Absorption Rate Constant (Ka) [ Time Frame: Day 28 and Day 56 ]
  2. 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.

  3. 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.

  4. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 28 and Day 56 ]
  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 28 and Day 56 ]
  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857896


Locations
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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, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00857896    
Other Study ID Numbers: A0221066
First Posted: March 9, 2009    Key Record Dates
Results First Posted: November 17, 2011
Last Update Posted: November 24, 2011
Last Verified: November 2011
Keywords provided by Pfizer:
Study of fesoterodine in pediatric overactive bladder patients
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Fesoterodine
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents