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

Urinary Bladder, Overactive Clinical Trial

Official title:

A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262391
• Other study ID #: 905-CL-075
• Secondary ID: 2009-017197-21
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2010
• Est. completion date: August 14, 2011

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 14, 2011
• Est. primary completion date: August 14, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Denmark,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Concentration (Cmax)		Day 1 predose up to Day 7 postdose
Primary	Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)		Day 1 predose up to Day 7 postdose
Primary	Apparent Terminal Elimination Half-life (t1/2)		Day 1 predose up to Day 7 postdose
Primary	Time to Attain Cmax (tmax)		Day 1 predose up to Day 7 postdose
Primary	Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)		Day 1 predose up to Day 7 postdose
Primary	Apparent Total Body Clearance (CL/F)		Day 1 predose up to Day 7 postdose
Primary	Apparent Volume of Distribution During the Terminal Phase (Vz/F)		Day 1 predose up to Day 7 postdose
Secondary	Number of Participants with Adverse Events (AEs)	Safety is monitored by collecting AEs, which includes abnormal laboratory tests, vital signs or ECG data that are defined as an AE if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study medication or is clinically significant in the investigator's opinion. A treatment-emergent adverse event (TEAE) is defined as an AE that occurs or worsens after study drug administration. A serious AE (SAE) is any untoward medical occurrence that, at any dose: Results in death, is life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events.	From the first dose of study drug up to 7 days postdose
Secondary	Change from baseline in postvoid residual (PVR) volume	PVR volume is assessed by ultrasonography or bladder scan.	Baseline (screening) and 4 hours postdose

External Links

•   Link to results on the Astellas Clinical Study Results website