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)
Verified date | October 2018 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Belgium, Denmark, Sweden, United Kingdom,
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 |
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