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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Neurogenic

Treatments: Drug: Fesoterodine BIC 4 mg; Drug: Fesoterodine PR 8 mg; Drug: Fesoterodine BIC 2 mg; Drug: Fesoterodine PR 4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02501928

A0221109

Details and patient eligibility

About

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.

Full description

This is a Phase 3, multi-center, open-label long-term extension study in Japanese NDO subjects who participated and completed in the precedent Study A0221047 which is a 24 weeks, randomized, open label study, to investigate the safety and tolerability of fesoterodine.

This study consists of a 28-week open-label treatment period followed by a 4-week follow-up. In addition, subjects in the oxybutynin arm of the precedent Study A0221047 will continue the fesoterodine treatment until Week 40 visit in this study, in order to obtain fesoterodine 1 year treatment data.

Enrollment: 12 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

•Subjects who completed 24 week treatment and all visit procedures in the precedent Study A0221047

Exclusion criteria

• Subjects who had major protocol violation (as determined by the Sponsor) in Study A0221047
• Concomitant medications which may increase the risk to subjects or confound study results
• Other medical conditions which may increase the risk to subjects or confound study results

Trial design

12 participants in 4 patient groups

Fesoterodine PR 4 mg

Experimental group

Description:

Fesoterodine PR 4 mg for 28 or 40 weeks in open-label treatment period

Treatment:

Drug: Fesoterodine PR 4 mg

Fesoterodine PR 8 mg

Experimental group

Description:

Fesoterodine PR 8 mg for 28 or 40 weeks in open-label treatment period

Treatment:

Drug: Fesoterodine PR 8 mg

Fesoterodine BIC 2 mg

Experimental group

Description:

Fesoterodine BIC 2 mg for 28 weeks in open-label treatment period

Treatment:

Drug: Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg

Experimental group

Description:

Fesoterodine BIC 4 mg for 28 weeks in open-label treatment period

Treatment:

Drug: Fesoterodine BIC 4 mg