A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

Pfizer

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Neurogenic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01557244

2010-022475-55 (EudraCT Number)

A0221047

Details and patient eligibility

About

The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.

Enrollment: 181 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 6 to 17 years old
• Subjects with stable neurological disease and neurogenic detrusor overactivity
• Subjects using clean intermittent catheterization may participate

Exclusion criteria

• 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
• Contraindications to the use of fesoterodine or oxybutynin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 5 patient groups

Fesoterodine PR 4 mg

Experimental group

Description:

Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period

Treatment:

Drug: Fesoterodine PR 4 mg

Fesoterodine PR 8 mg

Experimental group

Description:

Fesoterodine 8 mg for first week followed by 11 weeks at 8 mg in active control period, followed by 12 weeks in safety extension period.

Treatment:

Drug: Fesoterodine PR 8 mg

Drug: Fesoterodine PR 8 mg

Oxybutynin

Active Comparator group

Description:

Oxybutynin

Treatment:

Drug: Fesoterodine PR

Drug: Oxybutynin

Fesoterodine BIC 2 mg

Experimental group

Description:

Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.

Treatment:

Drug: Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg

Experimental group

Description:

Fesoterodine BIC 4 mg for first week followed by 11 weeks at 8 mg in the efficacy period, followed by 12 weeks in safety extension period.

Treatment:

Drug: Fesoterodine BIC 4 mg