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Completed

NCT Number: NCT00857896

Study 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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neurogenic Detrusor Overactivity Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fesoterodine

Drug

4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 9, 2009
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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