Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-20

Study Completion Date

2011-08-14

Brief Summary

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This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.

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Detailed Description

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This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.

The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.

Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AD-PED 2.5 mg

Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate.

Group Type EXPERIMENTAL

Solifenacin succinate suspension 2.5 mg

Intervention Type DRUG

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults.

AD-PED 5 mg

Male and female adolescents aged 12 to less than 18 years old who receive PED of 5 mg of solifenacin succinate.

Group Type EXPERIMENTAL

Solifenacin succinate suspension 5 mg

Intervention Type DRUG

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults.

AD-PED 10 mg

Male and female adolescents aged 12 to less than 18 years old who receive PED of 10 mg of solifenacin succinate.

Group Type EXPERIMENTAL

Solifenacin succinate suspension 10 mg

Intervention Type DRUG

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults.

CH-PED 2.5 mg

Male and female children aged 5 to less than 12 years old who receive PED of 2.5 mg of solifenacin succinate.

Group Type EXPERIMENTAL

Solifenacin succinate suspension 2.5 mg

Intervention Type DRUG

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults.

CH-PED 5 mg

Male and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate.

Group Type EXPERIMENTAL

Solifenacin succinate suspension 5 mg

Intervention Type DRUG

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults.

CH-PED 10 mg

Male and female children aged 5 to less than 12 years old who receive PED of 10 mg of solifenacin succinate.

Group Type EXPERIMENTAL

Solifenacin succinate suspension 10 mg

Intervention Type DRUG

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults.

Interventions

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Solifenacin succinate suspension 2.5 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults.

Intervention Type DRUG

Solifenacin succinate suspension 5 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults.

Intervention Type DRUG

Solifenacin succinate suspension 10 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults.

Intervention Type DRUG

Other Intervention Names

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YM905 YM905 YM905

Eligibility Criteria

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Inclusion Criteria

* Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
* Daytime urgency incontinence at least once/day

Exclusion Criteria

* Daytime voiding frequency less than 5
* Uroflow indicative of pathology other than OAB
* Maximum voided volume \> age expected capacity (\[age +1\] x 30) in ml
* Post voiding residual (PVR) \> 10% of the functional bladder capacity
* Monosymptomatic enuresis
* Congenital anomalies of the genito-urinary tract or nervous system
* Current constipation (when treated the patient can enter the study)
* Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative)
* Serum creatinine more than or equal to 2 times the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No