A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug (LION)

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Placebo; Drug: Solifenacin Succinate Suspension; Behavioral: Urotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565707

2011-002066-20 (EudraCT Number)

905-CL-076

Details and patient eligibility

About

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.

This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.

Enrollment: 189 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Written Informed Consent has been obtained
• OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
• Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary

Main Exclusion Criteria:

• Daily voiding frequency less than 5
• Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
• Uroflow indicative of pathology other than OAB
• Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml
• Post Void Residual (PVR) > 20 ml
• Monosymptomatic enuresis
• Polyuria defined as > 75 ml/kg/b.w./24 hours
• Dysfunctional voiding
• Congenital anomalies affecting lower urinary tract function
• Current constipation
• Current Urinary Tract Infection (UTI)
• Catheterization within 2 weeks prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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189 participants in 4 patient groups, including a placebo group

Placebo Children

Placebo Comparator group

Description:

Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.

Treatment:

Behavioral: Urotherapy

Drug: Placebo

Solifenacin Succinate Suspension Children

Experimental group

Description:

Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.

Treatment:

Behavioral: Urotherapy

Drug: Solifenacin Succinate Suspension

Placebo Adolescents

Placebo Comparator group

Description:

Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.

Treatment:

Behavioral: Urotherapy

Drug: Placebo

Solifenacin Succinate Suspension Adolescents

Placebo Comparator group

Description:

Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.

Treatment:

Behavioral: Urotherapy

Drug: Solifenacin Succinate Suspension