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Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

NCT02501928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-11-30

Study results available
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Summary

The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.

Conditions

  • Urinary Bladder, Neurogenic

Interventions

DRUG

Fesoterodine PR 4 mg

Fesoterodine 4 mg tablet once daily for 28 or 40 weeks

DRUG

Fesoterodine PR 8 mg

Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks

DRUG

Fesoterodine BIC 2 mg

Fesoterodine BIC 2 mg tablet once daily for 28 weeks

DRUG

Fesoterodine BIC 4 mg

Fesoterodine BIC 4 mg tablet once daily for 28 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-05
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02501928 on ClinicalTrials.gov