Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
27 de agosto de 2018 atualizado 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.
Visão geral do estudo
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
32
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
7 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Average Steady-state Concentration (Css, av) of Oxycodone
Prazo: 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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Apparent Oral Clearance (CL/F) of Oxycodone
Prazo: 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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Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
Prazo: 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
Prazo: Baseline up to Day 63
|
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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Apparent Volume of Distribution (Vz/F) of Oxycodone
Prazo: 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.
|
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.
Prazo: 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
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de janeiro de 2016
Conclusão Primária (Real)
10 de janeiro de 2018
Conclusão do estudo (Real)
24 de janeiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
20 de janeiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de fevereiro de 2016
Primeira postagem (Estimativa)
12 de fevereiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de setembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2018
Última verificação
1 de agosto de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B4531015
- ALO-02 PHASE 4 PEDIATRIC STUDY (Outro identificador: Alias Study Number)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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