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

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Pfizer

Status and phase

Completed
Phase 2

Conditions

Neurogenic Detrusor Overactivity
Overactive Bladder

Treatments

Drug: Fesoterodine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00857896
A0221066

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

8 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Fesoterodine once daily
Experimental group
Treatment:
Drug: Fesoterodine

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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