Primary Objective:To evaluate the efficacy and safety of solifenacin succinate o.d. in children and adolescents with OABSecondary Objective:To perform population pharmacokinetics after multiple-dose administration.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy variable:
· Change from baseline to EoT (final visit) in mean volume voided per
micturition. The mean voided volume will be determined using the patient diary
data of two days (e.g., during the weekend).
Secondary outcome
Efficacy variables:
Change from baseline to EoT (final visit) in each of:
· Maximum volume voided per micturition.
· Mean number of daytime incontinence episodes/24 h.
· Mean number of nighttime incontinence episodes/24 h.
· Mean number of incontinence episodes/24 h.
· Number of dry (incontinence-free) days/7 days
· Mean number of daytime micturitions/24 h.
· Mean number of micturitions/24h.
· Mean number of grade 3 or 4 urgency episodes per 24 h in
adolescents.
Safety variables:
· Incidence and severity of adverse events (AEs)
· Vital signs
· Laboratory tests (including hematology and biochemistry)
· Urinalysis
· Post void residual volume(PVR)
· 12-lead ECG parameters.
Pharmacokinetic variables:
· Maximum concentration (Cmax)
· Time to attain Cmax (tmax)
· Plasma concentration before drug administration (Ctrough)
· Area under the plasma -time curve (AUC) for a dose
interval (AUCtau)
· Apparent terminal elimination half-life (t1/2)
· Apparent Total Body Clearance (CL/F)
· Apparent volume of distribution (V/F).
Background summary
Solifenacin succinate as tablet formulation is a registered medicine developed
for the treatment of symptoms of overactive bladder in adults. For the use in
children and adolescent patients a new formulation of solifenacin has been
developed. The new formulation is a liquid that will be taken by mouth. In this
study, evidence will be collected for the efficacy and safety of Solifenacin
succinate suspension. (Section 1.1 of Protocol versie 29Sep2011)
Study objective
Primary Objective:
To evaluate the efficacy and safety of solifenacin succinate o.d. in children
and adolescents with OAB
Secondary Objective:
To perform population pharmacokinetics after multiple-dose administration.
Study design
This is a phase 3, double-blind, randomized, multi-center, placebo-controlled
sequential dose titration study.
Intervention
One group receives a dosage of solifenacin succinate suspension (oral
administration) once daily, and the other group will receive placebo once
daily.The starting dose of solifenacin succinate suspension will be adjusted
based on weight to deliver equivalent plasma drug exposure as the 5 mg dose of
solifenacin succinate in adults. This is referred to as the pediatric
equivalent dose of 5 mg (PED5). The subject
can be up or down titrated based to the equivalent doses to adult exposure of
2.5 mg, 5 mg , 7.5 mg and 10 mg.
Study burden and risks
Please refer section '7. Which side-effects and risks can your child expect?'
and 'Addendum V. Side effects' in the patient information for the parents.
The most common side effects and discomforts of solifenacin succinate are: Dry
mouth, constipation, blurred vision, indigestion, abdominal pain, nausea.
If the patient or his partner becomes pregnant this may have effects for the
unborn child.
In addition, the patient could have discomfort from the following procedures:
ECG: Slight skin irritation from the ECG electrodes can occur, but this is
generally mild and clears up within a few days.
Bloodtests: Blood will be taken from a needle or, at visit 7, a cannula (small
flexible plastic tube) that will be inserted in a vein in the arm. This
minimizes the use of needles, though sometimes (if the cannula becomes blocked)
a new needle may be needed. The patient may experience minor discomfort from
these procedures, and occasionally some bruising or irritation of the veins
used for blood sampling. These effects normally clear up completely in a few
days. Every effort will be made to reduce the anxiety felt by some children
e.g. during a blood test. Local anesthetic cream can be used to help numb any
pain.
Elisabethhof 19
Leiderdorp 2353 EW
NL
Elisabethhof 19
Leiderdorp 2353 EW
NL
Listed location countries
Age
Inclusion criteria
-OAB (symptoms of urgency) according to International Children*s Continence Society (ICCS) criteria and subject is dissatisfied with the licensed treatment options.
-Daytime incontinence with at least 4 or more episodes of incontinence
Exclusion criteria
-Daily voiding frequency less than 5.
-Uroflow indicative of pathology other than OAB.
-Maximum voided volume (morning volume excluded) at baseline (visit 3) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml.
-PVR > 20 ml
-Monosymptomatic enuresis
-Congenital anomalies (surgically treated or untreated) that affecting lower urinary tract function
-Current constipation
-Current UTI
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002066-20-NL |
| ClinicalTrials.gov | NCT01565707 |
| CCMO | NL39262.091.12 |