Overactive bladder (OAB) MedDRA version: 23.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Sponsors
Astellas Pharma Global Development Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion at Visit 1/Week -4 (Screening) 2. Subject has OAB defined according to the ICCS criteria. 4. Subject weighs at least 13 kg at screening. 5. Subject is able to take the IP in accordance with the protocol. 6. Subject agrees to drink an adequate fluid volume during urine collection weekends, as instructed by the investigator. 7. Subject and subject’s parent(s)/legal guardian(s) agree that the subject will not participate in another interventional study while participating in the present study. 8. Subject and subject’s parent(s)/legal guardian(s) are willing and able to comply with the study requirements and with the concomitant medication restrictions. 9. At least 1 of the following conditions apply: a. Not a female of childbearing potential b. Female of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent/assent through at least 30 days after final IP administration. 10. Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration. 11. Female subject must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration. 12. Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 30 days after final IP administration. 13. Male subject must agree not to donate sperm during the treatment period and for 30 days after final IP administration. 14. Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration. Additional Inclusion at Visit 3/Week 0 (Baseline) 15. Subject must have a micturition frequency of at least 8 times (on average) per day, in the 7 days prior to visit 3/week 0 (baseline), as recorded in the bladder e-diary. 16. Subject must have at least 1 daytime incontinence episode (on average) per day, during the 7-day period before visit 3/baseline, as recorded in the bladder e-diary. 17. Subject whose symptoms are not satisfactorily controlled with urotherapy and still fulfills the inclusion/exclusion criteria will enter the study. Are the trial subjects under 18? yes Number of subjects for this age range: 432 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion at Visit 1/Week -4 (Screening) 1. Subject has extraordinary daytime only urinary frequency according to the ICCS definition ? This applies to a toilet-trained child who has the frequent need to void that is associated with small micturition volumes solely during the day ? The daytime voiding frequency is at least once per hour with an average voided volume of 440 msec on screening ECG, or a risk of QT prolongation (e.g., hypokalemia, long QT syndrome [LQTS] or family history of LQTS or exercise-induced syncope) or is currently taking medication known to prolong the QT interval 13. Subject’s aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is = 2 × upper limit of normal (ULN) or total bilirubin (TBL) is = 1.5 × ULN according to age and sex (subjects with Gilbert’s syndrome are excepted from the bilirubin threshold) 14. mild or moderate renal impairment (estimated glomerular filtration rate according to the modified Schwartz of < 60 mL/min per 1.73 m2) 15. a symptomatic (symptoms can include pain, fever, hematuria, new onset foul-smelling urine) UTI. Note: if the UTI is treated successfully (clinical recovery: confirmed by dipstick test and repeated dipstick test after 14 days [both should be negative]), the subject can be rescreened 16. a history or presence of any malignancy 17. uses any drugs that are sensitive cytochrome P450 2D6 (CYP2D6) substrates with a narrow therapeutic index, sensitive P-glycoprotein (P-gp) substrates, or moderate or strong cytochrome CYP3A4/5 or P-gp inhibitors or inducers after the start of washout 18. is using or has used prohibited prior and/or concomitant medication(s) that cannot be discontinued 19. known or suspected hypersensitivity to mirabegron or any components of the formulations used 20. participated in another clinical study (and/or subject has received any investigational therapy within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1/week -4 (screening) 21. received urinary catheterization within 2 weeks prior to screening 22. Constipation as defined by the Rome IV criteria that cannot be successfully treated prior to study entry 23. Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening 24. any condition which makes the subject unsuitable for study participation Additional Exclusion at Visit 3/Week 0 (Baseline) Subject has 25. extraordinary daytime only urinary frequency according to the ICCS d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB;Secondary Objective: ? To evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB ? To evaluate the safety and tolerability of mirabegron in pediatric subjects with OAB ? To evaluate the pharmacokinetics after multiple dose administration of mirabegron in pediatric subjects with OAB;Primary end point(s): Change from baseline at the end of the 12-week treatment period: Mean number of micturitions per 24 hours;Timepoint(s) of evaluation of this end point: at the end of the 12-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Change from baseline at the end of the 12-week treatment period: ? Mean volume voided per 24 hours ? Maximum volume voided ? Mean number of daytime incontinence episodes per 24 hours ? Mean number of nighttime incontinence episodes per 24 hours ? Mean number of daytime micturitions per 24 hours ? Number of dry (incontinence-free) days per 7 days at the end of the 12-week treatment ? Nature, frequency and severity of AEs ? Clinical laboratory tests (hematology, biochemistry and urinalysis) ? Vital signs (blood pressure and pulse) ? Routine 12-lead ECG ? PVR volume ? Acceptability and palatability questionnaire ? Steady-state Cmax, AUCtau, Ctrough, Tmax, CL/F, and Vz/F. Additional parameters may be calculated based on the population pharmacokinetic model used;Timepoint(s) of evaluation of this end point: throughout and at the end of the 12-week treatment period | — |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Korea, Democratic People's Republic of, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V., Global Development Operations
Outcome results
None listed