A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
- Conditions
- Overactive Bladder (OAB)Pharmacokinetics of Mirabegron
- Registration Number
- NCT04641975
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria:<br><br> - Subject has OAB defined according to the International Children's Continence Society<br> (ICCS) criteria.<br><br> - Subject weighs at least 13 kg at screening.<br><br> - Subject is able to take the IP in accordance with the protocol.<br><br> - Subject agrees to drink an adequate fluid volume during urine collection weekends.<br><br> - Subject and subject's parent(s)/legal guardian(s) agree that the subject will not<br> participate in another interventional study while participating in the present<br> study.<br><br> - Subject and subject's parent(s)/legal guardian(s) are willing and able to comply<br> with the study requirements and with the concomitant medication restrictions.<br><br> - Female subject is not pregnant and at least 1 of the following conditions apply:<br><br> - Not a female of childbearing potential<br><br> - Female of child bearing potential who agrees to follow the contraceptive<br> guidance from the time of informed consent/assent through at least 30 days<br> after final IP administration.<br><br> - Female subject must agree not to breastfeed starting at screening and throughout the<br> study period and for 30 days after final IP administration.<br><br> - Female subject must not donate ova starting at first dose of IP and throughout the<br> study period and for 30 days after final IP administration.<br><br> - Male subject with female partner(s) of childbearing potential (including<br> breastfeeding partner[s]) must agree to use contraception throughout the treatment<br> period and for 30 days after final IP administration.<br><br> - Male subject must agree not donate sperm during the treatment period and for 30 days<br> after final IP administration.<br><br> - Male subject with pregnant partner(s) must agree to remain abstinent or use a condom<br> for the duration of the pregnancy throughout the study period and for 30 days after<br> final IP administration.<br><br>Additional Inclusion at Visit 3/Week 0 (Baseline)<br><br> - Subject must have a micturition frequency of at least 8 times (on average) per day,<br> in the 7 days prior to visit 3/week 0 (baseline), as recorded in the bladder<br> e-diary.<br><br> - Subject must have at least 1 daytime incontinence episode (on average) per day,<br> during the 7-day period before visit 3/baseline, as recorded in the bladder e-diary.<br><br> - Subject whose symptoms are not satisfactorily controlled with urotherapy and still<br> fulfills the inclusion/exclusion criteria will enter the study.<br><br>Exclusion Criteria:<br><br>Exclusion at Visit 1/Week -4 (Screening)<br><br> - Subject has extraordinary daytime only urinary frequency according to the ICCS<br> definition.<br><br> - This applies to a toilet-trained child who has the frequent need to void that<br> is associated with small micturition volumes solely during the day.<br><br> - The daytime voiding frequency is at least once per hour with an average voided<br> volume of < 50% of expected bladder capacity (EBC) (typically 10% to 15%).<br><br> - Incontinence is rare and nocturia is absent.<br><br> - Subject has an uroflow indicative of pathology other than OAB.<br><br> - Subject has monosymptomatic enuresis.<br><br> - Subject has dysfunctional voiding.<br><br> - Subject has bladder outlet obstruction, except if successfully treated.<br><br> - Subject has anatomical anomalies (surgically treated or untreated) that affect lower<br> urinary tract function.<br><br> - Subject with hematuria on dipstick test. In the case of hematuria on dipstick test<br> in a female during menstruation, the test can be repeated before randomization<br> (after the end of menstruation).<br><br> - Subject with diabetes insipidus.<br><br> - Subject has kidney or bladder stones.<br><br> - Subject has suffered from chronic UTI or has had more than 3 UTIs in the 2 months<br> prior to visit 1/week -4 (screening).<br><br> - Subject has stage 2 hypertension or subject has stage 1 hypertension that is not<br> well controlled, as defined by the 2017 American Academy of Pediatrics Clinical<br> Practice Guidelines.<br><br> - Subject has QT interval using Fridericia's correction formula (QTcF) > 440 msec on<br> screening ECG, risk of QT prolongation (e.g., hypokalemia, long QT syndrome [LQTS]<br> or family history of LQTS or exercise-induced syncope) or is currently taking<br> medication known to prolong the QT interval.<br><br> - Subject's aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is = 2<br> × upper limit of normal (ULN) or total bilirubin (TBL) is = 1.5 × ULN according to<br> age and sex (subjects with Gilbert's syndrome are excepted from the bilirubin<br> threshold).<br><br> - Subject has mild or moderate renal impairment (estimated glomerular filtration rate<br> according to the modified Schwartz of < 60 mL/min per 1.73 m^2).<br><br> - Subject has a symptomatic (symptoms can include pain, fever, hematuria, new onset<br> foul-smelling urine) UTI. Note: if the UTI is treated successfully (clinical<br> recovery: confirmed by dipstick test and repeated dipstick test after 14 days [both<br> should be negative]), the subject can be rescreened.<br><br> - Subject has a history or presence of any malignancy.<br><br> - Subject uses any drugs that are sensitive cytochrome P450 2D6 (CYP2D6) substrates<br> with a narrow therapeutic index or sensitive P-glycoprotein (P-gp) substrates, or<br> moderate or strong cytochrome CYP3A4/5 or P-gp inhibitors or inducers after the<br> start of washout.<br><br> - Subject is using or has used prohibited prior and/or concomitant medication(s) that<br> cannot be discontinued.<br><br> - Subject has known or suspected hypersensitivity to mirabegron or any components of<br> the formulations used.<br><br> - Subject has participated in another clinical study (and/or subject has received any<br> investigational therapy within 30 days (or 5 half-lives of the drug, or the limit<br> set by national law, whichever is longer) prior to visit 1/week -4 (screening).<br><br> - Subject received urinary catheterization within 2 weeks prior to screening.<br><br> - Subject has constipation as defined by the Rome IV criteria that cannot be<br> successfully treated prior to study entry.<br><br> - Female subject who has been pregnant within 6 months prior to screening or<br> breastfeeding within 3 months prior to screening.<br><br> - Subject has any condition that makes the subject unsuitable for study participation.<br><br>Additional Exclusion at Visit 3/Week 0 (Baseline)<br><br> - Subject has extraordinary daytime only urinary frequency according to the ICCS<br> definition based on the bladder e-diary.<br><br> - Subject has monosymptomatic enuresis confirmed by the bladder e-diary.<br><br> - Subject has a maximum voided volume (morning volume excluded) > expected bladder<br> capacity (EBC) for age ([age +1] × 30) in mL, based on the bladder e-diary.<br><br> - Subject has polyuria defined as voided urine volumes of > 40 mL/kg baseline body<br> weight during 24 hours or > 2.8 L urine for a child weighing = 70 kg (ICCS<br> definition), based on bladder e-diary.<br><br> - Subject has PVR volume > 20 mL (lowest PVR volume result) as measured by<br> ultrasonography.<br><br> - Subject suffers from a symptomatic (symptoms can include pain, fever, hematuria, new<br> onset foul-smelling urine) urinary tract infection (UTI). Note: if a symptomatic UTI<br> is present, all visit 3/week 0 (baseline) assessments must be postp
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years
- Secondary Outcome Measures
Name Time Method