A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076 (LEOPARD)

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Solifenacin succinate suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01655069

905-CL-077

2011-002047-10 (EudraCT Number)

Details and patient eligibility

About

This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

Full description

There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.

Enrollment: 148 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076

Exclusion criteria

• Subject has failed the exclusion criteria of study 905-CL-076

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 4 patient groups

Children Treated with Placebo in 905-CL-076

Experimental group

Description:

Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.

Treatment:

Drug: Solifenacin succinate suspension

Children Treated with Solifenacin in 905-CL-076

Experimental group

Description:

Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.

Treatment:

Drug: Solifenacin succinate suspension

Adolescents Treated with Placebo in 905-CL-076

Experimental group

Description:

Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.

Treatment:

Drug: Solifenacin succinate suspension

Adolescents Treated with Solifenacin in 905-CL-076

Experimental group

Description:

Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.

Treatment:

Drug: Solifenacin succinate suspension