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

Resumen del estudio

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.

Más información del estudio

Fase

Fase 3

Producto

mirabegron + solifenacin succinate

Producto

Mirabegron

Placebo

Tipo

Interventional

Enmascaramiento

Double (Participant, Investigator)

Número de inscripción

432

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Información del solicitante [Soy...]

A caregiver
A healthcare provider
A parent
A patient
A patient advocate

Nombre

Apellido

Correo

País/región

Alemania
Anteriormente Serbia y Montenegro
Arabia Saudita
Argelia
Argentina
Armenia
Australia
Austria
Bélgica
Bielorrusia
Bosnia y Herzegovina
Brasil
Bulgaria
Canadá
Chile
China
Colombia
Croacia
Dinamarca
Egipto
Eslovaquia
Eslovenia
España
Estados Unidos
Estonia
Federación de Rusia
Filipinas
Finlandia
Francia
Georgia
Grecia
Guatemala
Hong Kong
Hungría
India
Indonesia
Irlanda
Islandia
Israel
Italia
Japón
Jordania
Kazajistán
Letonia
Líbano
Lituania
Macedonia
Malasia
Marruecos
México
Montenegro
Noruega
Nueva Zelanda
Países Bajos
Panamá
Perú
Polonia
Portugal
Puerto Rico
Reino Unido
República Checa
República de Corea
República de Moldavia
República Dominicana
Rumania
Serbia
Singapur
Sudáfrica
Suecia
Suiza
Tailandia
Taiwán, provincia de China
Turquía
Ucrania
Vietnam

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Ubicaciones

Contáctenos

Reclutamiento

Site ML60002

Kuala Lumpur, Malasia, 50586

Contáctenos

Reclutamiento

Site ML60003

Penang, Malasia, 10990

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Reclutamiento

Site KR82001

Seoul, Seoul Teugbyeolsi, República de Corea, 5505

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Reclutamiento

Site KR82002

Seoul, Seoul Teugbyeolsi, República de Corea, 3080

Contáctenos

Reclutamiento

Site KR82003

Seoul, Seoul Teugbyeolsi, República de Corea, 3772

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Site KR82004

Yangsan-Si, Gyeongsangnamdo, República de Corea, 50612

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Reclutamiento

Site NL31001

Deventer, Overijssel, Países Bajos, 7416 SE

Contáctenos

Reclutamiento

Site RU70001

Kazan, Tatarstan, Respublika, Federación de Rusia, 420138

Contáctenos

Reclutamiento

Site TR90001

Bursa, Bursa, Turquía, 16059

Contáctenos

Reclutamiento

Site CA15006

London, Ontario, Canadá, ON N6A 5W9

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Reclutamiento

Site PH63002

Angeles City, Filipinas, 2009

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Reclutamiento

Site PH63004

Cebu City, Filipinas, 6000

Contáctenos

Reclutamiento

Site PH63005

Quezon City, Filipinas, 1113

Contáctenos

Reclutamiento

Site PH63007

Davao City, Filipinas, 8000

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Reclutamiento

Site RU70008

Yekaterinburg, Federación de Rusia, 620134

Contáctenos

Reclutamiento

Site TR90003

Mersin, Içel, Turquía, 33343

Contáctenos

Reclutamiento

Site BE32002

Kortrijk, Bélgica, 8500

Contáctenos

Información del estudio

Estudio de seguimiento

Edad

5 - 17 Years

Afección

Vejiga hiperactiva

Otros

Sexo

Mujer y hombre

Fechas del estudio

Apr 2021 - May 2023

Compartir con

Más información del estudio

Criterios de inclusión

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.

Criterios de exclusión

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.

Preguntas frecuentes

¿Los estudios clínicos son solo para personas con cáncer avanzado?

Si bien algunos estudios clínicos pueden enfocarse en cánceres más avanzados, muchos estudios están abiertos para pacientes con cáncer en diferentes etapas. Cada estudio tiene reglas que establecen quiénes pueden participar. Por ejemplo, quizás solo puedan participar pacientes de un grupo de edad determinado o aquellos que tengan un tipo determinado de tumor.

¿Será necesario que interrumpa mi tratamiento actual para participar en un estudio clínico?

A veces los investigadores quieren que los participantes sigan recibiendo sus tratamientos actuales durante un estudio clínico. En otras ocasiones, es posible que deba interrumpir sus tratamientos actuales durante un tiempo. Si el tratamiento en investigación no funciona, siempre puede volver a su plan de tratamiento original.

¿Debería preocuparme la posibilidad de recibir placebo?

En los estudios clínicos oncológicos, solo se usa placebo si no hay otro tratamiento disponible para ese tipo de cáncer. Esto ayuda a comparar un tratamiento en investigación con el placebo. Los placebos rara vez se usan en estudios oncológicos, porque en su lugar generalmente se administra el mejor tratamiento disponible, que se denomina “estándar de atención”.

¿Necesito una derivación de mi médico para participar en un estudio?

Es posible que su médico no conozca todas las oportunidades de participación en estudios clínicos que usted tiene a su disposición. Hable con su médico o con otro profesional de la salud sobre la información que encuentre en relación con un estudio clínico. Podrán ayudarlo a decidir si el estudio clínico es adecuado para usted. Si no encuentra ninguna opción en este sitio web, le recomendamos que visite un registro público en línea, por ejemplo, clinicaltrials.gov para conocer los diversos estudios clínicos que están disponibles.

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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)

Resumen del estudio

Más información del estudio

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Ubicaciones

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