A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB), Trial ID 178-CL-204

试验摘要

The purpose of this study is to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB.

This study will also evaluate the safety and tolerability of mirabegron in pediatric participants with OAB and evaluate the pharmacokinetics after multiple dose administration of mirabegron in pediatric participants with OAB.

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吉隆坡, 马来西亚, 50586

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Penang, 马来西亚, 10990

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首尔, 首尔特别市, 韩国, 5505

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首尔, 首尔特别市, 韩国, 3080

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首尔, 首尔特别市, 韩国, 3772

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Yangsan-Si, Gyeongsangnamdo, 韩国, 50612

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Deventer, Overijssel, 荷兰, 7416 SE

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Kazan, Tatarstan, Respublika, 俄罗斯联邦, 420138

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布尔萨, 布尔萨, 土耳其, 16059

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研究中心 CA15006

伦敦, 安大略省, 加拿大, ON N6A 5W9

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研究中心 PH63002

Angeles City, 菲律宾, 2009

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Cebu City, 菲律宾, 6000

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Quezon City, 菲律宾, 1113

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Davao City, 菲律宾, 8000

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Yekaterinburg, 俄罗斯联邦, 620134

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Mersin, Içel, 土耳其, 33343

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Kortrijk, 比利时, 8500

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试验信息

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参与者年龄

5 - 17 Years

疾病

膀胱过度活动症

其他

参与者性别

女性和男性

试验开展时间

2021年4月 - 2023年5月

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入选标准

Subject has OAB defined according to the International Children’s Continence Society (ICCS) criteria.
Subject weighs at least 13 kg at screening.
Subject is able to take the IP in accordance with the protocol.
Subject agrees to drink an adequate fluid volume during urine collection weekends.
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.
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.
Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a female of childbearing potential
- Female of child bearing potential who agrees to follow the contraceptive guidance from the time of informed consent/assent through at least 30 days after final IP administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
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.
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.
Male subject must agree not donate sperm during the treatment period and for 30 days after final IP administration.
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)

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.
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.
Subject whose symptoms are not satisfactorily controlled with urotherapy and still fulfills the inclusion/exclusion criteria will enter the study.

排除标准

Exclusion at Visit 1/Week -4 (Screening)

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 < 50% of expected bladder capacity (EBC) (typically 10% to 15%).
- Incontinence is rare and nocturia is absent.
Subject has an uroflow indicative of pathology other than OAB.
Subject has monosymptomatic enuresis.
Subject has dysfunctional voiding.
Subject has bladder outlet obstruction, except if successfully treated.
Subject has anatomical anomalies (surgically treated or untreated) that affect lower urinary tract function.
Subject with hematuria on dipstick test. In the case of hematuria on dipstick test in a female during menstruation, the test can be repeated before randomization (after the end of menstruation).
Subject with diabetes insipidus.
Subject has kidney or bladder stones.
Subject has suffered from chronic UTI or has had more than 3 UTIs in the 2 months prior to visit 1/week -4 (screening).
Subject has stage 2 hypertension or subject has stage 1 hypertension that is not well controlled, as defined by the 2017 American Academy of Pediatrics Clinical Practice Guidelines.
Subject has QT interval using Fridericia’s correction formula (QTcF) > 440 msec on screening ECG, 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.
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).
Subject has mild or moderate renal impairment (estimated glomerular filtration rate according to the modified Schwartz of < 60 mL/min per 1.73 m^2).
Subject has 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.
Subject has a history or presence of any malignancy.
Subject uses any drugs that are sensitive cytochrome P450 2D6 (CYP2D6) substrates with a narrow therapeutic index or sensitive P-glycoprotein (P-gp) substrates, or moderate or strong cytochrome CYP3A4/5 or P-gp inhibitors or inducers after the start of washout.
Subject is using or has used prohibited prior and/or concomitant medication(s) that cannot be discontinued.
Subject has known or suspected hypersensitivity to mirabegron or any components of the formulations used.
Subject has 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).
Subject received urinary catheterization within 2 weeks prior to screening.
Subject has constipation as defined by the Rome IV criteria that cannot be successfully treated prior to study entry.
Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
Subject has any condition that makes the subject unsuitable for study participation.

Additional Exclusion at Visit 3/Week 0 (Baseline)

Subject has extraordinary daytime only urinary frequency according to the ICCS definition based on the bladder e-diary.
Subject has monosymptomatic enuresis confirmed by the bladder e-diary.
Subject has a maximum voided volume (morning volume excluded) > expected bladder capacity (EBC) for age ([age +1] × 30) in mL, based on the bladder e-diary.
Subject has polyuria defined as voided urine volumes of > 40 mL/kg baseline body weight during 24 hours or > 2.8 L urine for a child weighing ≥ 70 kg (ICCS definition), based on bladder e-diary.
Subject has PVR volume > 20 mL (lowest PVR volume result) as measured by ultrasonography.
Subject suffers from a symptomatic (symptoms can include pain, fever, hematuria, new onset foul-smelling urine) urinary tract infection (UTI). Note: if a symptomatic UTI is present, all visit 3/week 0 (baseline) assessments must be postponed until the UTI is successfully treated (clinical recovery: confirmed by dipstick test and repeated dipstick test after 14 days [both should be negative]), and the urotherapy should continue. The postponed visit 3/week 0 (baseline) should be within 14 days of the intended visit 3/week 0 (baseline).
Subject with hematuria on dipstick test. In the case of hematuria on dipstick test in a female during menstruation, the test can be repeated before randomization (after the end of menstruation).
Subject has a pulse > 99th percentile for age.
Subject has stage 2 hypertension or subject has stage 1 hypertension that is not well controlled, as defined by the 2017 American Academy of Pediatrics Clinical Practice Guidelines.
Any reason that makes the subject unsuitable for study participation.

常见问题

临床试验是否只针对晚期癌症患者？

虽然某些临床试验可能侧重于更晚期的癌症，但许多试验对处于不同癌症阶段的患者开放。每项研究都有关于参与资格的规定。例如，只有特定年龄段的患者或患有特定类型肿瘤的患者才能参与。

我是否需要停止当前治疗才能参加临床试验？

有时，研究人员希望参与者在临床试验期间继续接受当前治疗。有时，您可能需要暂停当前的治疗。如果研究性治疗无效，您通常可以恢复原有的治疗方案。

我是否应该担心会服用安慰剂？

在癌症临床试验中，只有当该类癌症尚无其他治疗方法时，才会使用安慰剂。这有助于将研究性治疗与安慰剂进行比较。安慰剂在癌症试验中很少使用，因为通常会采用最佳可用疗法，即所谓的“标准治疗方案”。

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您的医生可能并不了解所有可供您参与的临床试验机会。请与您的医生或其他医疗服务提供者讨论您所找到的临床试验信息。他们可以帮助您判断临床试验是否适合您。若您在本网站未找到任何选择，建议访问临床试验注册网站（如 clinicaltrials.gov），以查看各类可参与的临床试验。

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A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

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