- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01262391
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
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)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
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Kortrijk, Belgium, 8500
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Arhus, Denmark, 8200
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Goteborg, Sweden, 41685
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Uppsala, Sweden, 75185
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Cambridge, United Kingdom, CB2 2QQ
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Manchester, United Kingdom, M13 9WL
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Sheffield, United Kingdom, S10 2TH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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Experimental: 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.
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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.
Other Names:
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Experimental: 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.
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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.
Other Names:
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Experimental: 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.
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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.
Other Names:
|
Experimental: 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.
|
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.
Other Names:
|
Experimental: 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum Concentration (Cmax)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Time to Attain Cmax (tmax)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Apparent Total Body Clearance (CL/F)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time Frame: Day 1 predose up to Day 7 postdose
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Day 1 predose up to Day 7 postdose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants with Adverse Events (AEs)
Time Frame: From the first dose of study drug up to 7 days postdose
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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.
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From the first dose of study drug up to 7 days postdose
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Change from baseline in postvoid residual (PVR) volume
Time Frame: Baseline (screening) and 4 hours postdose
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PVR volume is assessed by ultrasonography or bladder scan.
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Baseline (screening) and 4 hours postdose
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
Other Study ID Numbers
- 905-CL-075
- 2009-017197-21 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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