- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539707
Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder
A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Gent, Belgium, 9000
- Site: 3201
-
-
-
-
Quebec
-
Québec City, Quebec, Canada, G1V 4G2
-
-
-
-
-
Århus N, Denmark, DK-8200
- Site: 4501
-
-
-
-
-
Utrecht, Netherlands, 3584 EA
- Site: 3102
-
-
-
-
-
Warszawa, Poland, 04-730
- Site: 4801
-
-
-
-
-
Ankara, Turkey, 6100
- Site: 90
-
-
-
-
-
Sheffield, United Kingdom, S10 2TH
- Site: 44
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Documented diagnosis of NDO, confirmed by urodynamics
- Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts
- Subject's bowel function is being actively managed
- Able to swallow the study medication in accordance to the protocol
- Female subjects of childbearing potential and sexually active agree to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment. Sexually active male subjects agree to use a barrier method of birth control for the duration of the study and for at least one month after ending study treatment
- Subject and subject's parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions
Exclusion Criteria:
At screening:
- Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test
- Subject with any of the following gastrointestinal (GI)conditions: partial or complete bowel obstruction, decreased motility (e.g., paralytic ileus) or at risk for gastric retention
- Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years
- History of QTc prolongation or risk of QT prolongation (e.g., hypokalemia, family history of Long QT Syndrome [LQTS]). QT interval greater than 470 ms at baseline
- Any clinically significant abnormality on ECG
- History or current diagnosis of any malignancy
- Diagnosis of central or X chromosome-linked diabetes insipidus
- Cystatine C is greater than or equal to 2 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the ULN or total bilirubin greater than or equal to 1.5 times the ULN
- Any other clinically significant out of range results of urinalysis, biochemistry or hematology
- Known or suspected hypersensitivity to solifenacin (or other anticholinergics), any of the excipients used in the current formulation or previous severe hypersensitivity to any drug
- Subject has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug whichever is longer) prior to Day 1
- Requires ongoing treatment with any of the following prohibited medications: antimuscarinic therapy, tricyclic/tetracyclic antidepressants, H1 antihistamines, strong CYP3A4 inhibitors, strong CYP3A4 inducers (many antiepileptic drugs like carbamazepine, phenytoin and phenobarbital)
- Mean systolic blood pressure greater than the 95th percentile according to age and height and/or greater than 140 mmHg [National Institute of Health, 2005], judged as clinically significant by the investigator
- Subject's parent(s)/legal guardian is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site executing the study
At Day 1:
- Consumption of grapefruit and products made of it (e.g., juice), and Seville oranges and products made of it (e.g., marmalade) within 14 days prior to Day 1
- Positive drug screen test for drugs of abuse at Day 1
- Positive alcohol breath test at Day 1
Use of prohibited prior and concomitant medication:
- Antimuscarinics, tricyclic/tetracyclic antidepressants, H1
antihistamines within 5 half-lives prior to intake of study drug at Day 1
Prescribed or over the counter (OTC) drugs that are potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), CYP3A4 substrates with higher affinity (e.g., verapamil, diltiazem), or potent CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine), including natural and herbal remedies (e.g., St. John's Wort) within 14 days prior to intake of study drug at Day 1
- Donation of blood or blood products within 3 months prior to Day 1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).
Other Names:
|
Experimental: AD-PED 5 mg
Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (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 dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Time Frame: Day 1 predose up to Day 7 postdose
|
Day 1 predose up to Day 7 postdose
|
Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Day 1 predose up to Day 7 postdose
|
Day 1 predose up to Day 7 postdose
|
Time to Attain Cmax (tmax)
Time Frame: Day 1 predose up to Day 7 postdose
|
Day 1 predose up to Day 7 postdose
|
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
|
Day 1 predose up to Day 7 postdose
|
Apparent Total Body Clearance (CL/F)
Time Frame: Day 1 predose up to Day 7 postdose
|
Day 1 predose up to Day 7 postdose
|
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time Frame: Day 1 predose up to Day 7 postdose
|
Day 1 predose up to Day 7 postdose
|
Maximum concentration (Cmax)
Time Frame: Day 1 predose up to Day 7 postdose
|
Day 1 predose up to Day 7 postdose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events (AEs)
Time Frame: From the first dose of study drug up to 7 days postdose
|
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
|
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-079
- 2011-000250-28 (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.
Clinical Trials on Overactive Bladder
-
Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
-
Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
-
Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
-
Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
-
Loyola UniversityAstellas Pharma IncCompletedOveractive Bladder SyndromeUnited States
-
Beijing Pins Medical Co., LtdUnknown
-
Maastricht University Medical CenterUnknownLower Urinary Tract Symptoms | Overactive Bladder SyndromeNetherlands
-
Pamukkale UniversityCompletedElectrical Stimulation | Idiopathic Overactive Bladder | Bladder TrainingTurkey
Clinical Trials on Solifenacin succinate suspension 5 mg
-
Astellas Pharma IncCompletedUrinary Bladder, OveractiveSweden, United Kingdom, Belgium, Denmark
-
Astellas Pharma Europe B.V.CompletedPediatric | Neurogenic Detrusor OveractivityUnited States, Belgium, Korea, Republic of, Philippines, Poland, United Kingdom
-
Genuine Research Center, EgyptHikma PharmaCompleted
-
Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin Succinate | Bioavailability of Solifenacin SuccinateUnited States
-
Astellas Pharma Europe B.V.CompletedUrinary Bladder, OveractiveBelgium, United States, Brazil, Canada, Denmark, Former Serbia and Montenegro, Korea, Republic of, Mexico, Norway, Philippines, Poland, South Africa, Sweden, Turkey, Ukraine, United Kingdom
-
Beni-Suef UniversityCompletedVoiding DisordersEgypt
-
Hanmi Pharmaceutical Company LimitedCompleted
-
Chang Gung Memorial HospitalUnknownOveractive Bladder Syndrome | Detrusor Overactivity
-
Astellas Pharma Europe B.V.CompletedLower Urinary Tract Symptoms | Benign Prostatic HyperplasiaBelgium, Italy, France, Austria, United Kingdom, Netherlands, Hungary, Russian Federation, Poland, Slovakia, Czech Republic, Belarus, Germany
-
Astellas Pharma Europe B.V.CompletedUrinary Bladder, OveractiveBelgium, United States, Brazil, Canada, Denmark, Former Serbia and Montenegro, Korea, Republic of, Mexico, Norway, Philippines, Poland, South Africa, Sweden, Turkey, Ukraine, United Kingdom