Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
27 de agosto de 2018 actualizado por: Pfizer
An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
Descripción general del estudio
Descripción detallada
This is a multicenter, open-label, single-arm study designed to characterize the PK and to evaluate the safety of ALO-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain.
The study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks.
The study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period to satisfy the PK endpoint.
A safety follow-up visit is required at 1 week post-last dose.
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Lancaster, California, Estados Unidos, 93534
- Research Center For Clinical Studies-West, Inc.
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Los Angeles, California, Estados Unidos, 90027
- Children's Hospital of Los Angeles - University of Southern California School of Medicine
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Los Angeles, California, Estados Unidos, 90027
- Children's Hopsital Los Angeles
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Sacramento, California, Estados Unidos, 95817
- University of California Davis
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Sacramento, California, Estados Unidos, 95817
- Shriners Hospitals For Children Northern California
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Sacramento, California, Estados Unidos, 95817
- UC Davis Health Attn: Peter Trovitch, PharmD
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago Clinical Research Center
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Hospital and Health Sciences Systems
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Hospital at the Medical Center
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North Carolina
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Greenville, North Carolina, Estados Unidos, 27834
- Leo Jenkins Cancer Center Pharmacy
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Greenville, North Carolina, Estados Unidos, 27834
- East Carolina University Brody School of Medicine(ECU)
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina Children's Hospital
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina, SCTR Research Nexus
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina, Investigational Drugs Services
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
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Texas
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San Antonio, Texas, Estados Unidos, 78249
- Road Runner Research, Ltd
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
7 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
- Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to > 6 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing.
Exclusion Criteria:
- Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
- Hypersensitivity to morphine, naltrexone.
- A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
- Undergone surgery within 3 days prior to the first day of dosing.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ALO-02
One arm, open label, active
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Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average Steady-state Concentration (Css, av) of Oxycodone
Periodo de tiempo: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl.
Oxycodone is a main component of this product.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Apparent Oral Clearance (CL/F) of Oxycodone
Periodo de tiempo: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl.
Oxycodone is a main component of this product.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
Periodo de tiempo: Baseline up to Day 63
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An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage.
All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage.
Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage.
The majority of AEs were of mild to moderate severity.
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Baseline up to Day 63
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Number of All-causality and Treatment-related AEs, by Intensity
Periodo de tiempo: Baseline up to Day 63
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An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage.
All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage.
Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage.
The majority of AEs were of mild to moderate severity.
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Baseline up to Day 63
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Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline up to Day 63
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An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage.
Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage.
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Baseline up to Day 63
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Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
Periodo de tiempo: Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
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The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal.
A subject assessed with a COWS score>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment.
The total COWS score ranges from 0 to 48.
Higher scores indicate worse outcome.
Different score ranges represent different severities of withdrawal: no withdrawal (<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (>36)
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Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Apparent Volume of Distribution (Vz/F) of Oxycodone
Periodo de tiempo: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
|
ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl.
Oxycodone is a main component of this product.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.
Periodo de tiempo: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
Periodo de tiempo: Baseline up to Day 58
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Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate.
In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) >= 30 mmHg and diastolic blood pressure (DBP) >=20 mmHg criteria.
None of the vital sign changes were clinically significant.
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Baseline up to Day 58
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Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
Periodo de tiempo: Baseline up to Day 77
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Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %).
Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase.
None of the lab abnormalities were clinically significant.
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Baseline up to Day 77
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de enero de 2016
Finalización primaria (Actual)
10 de enero de 2018
Finalización del estudio (Actual)
24 de enero de 2018
Fechas de registro del estudio
Enviado por primera vez
20 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
9 de febrero de 2016
Publicado por primera vez (Estimar)
12 de febrero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B4531015
- ALO-02 PHASE 4 PEDIATRIC STUDY (Otro identificador: Alias Study Number)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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