An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain (Palladone)
19 de outubro de 2015 atualizado por: Purdue Pharma LP
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
Visão geral do estudo
Descrição detalhada
Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects.
Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator determined the timing of the first dose based on each subject's clinical condition.
The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period).
Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for both the oral and parenteral treatments.
Tipo de estudo
Intervencional
Inscrição (Real)
116
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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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72202
- Arkansas Children's Hospital
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California
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County - Pediatric Subspecialty
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Stanford, California, Estados Unidos, 94305
- Stanford University Medical Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80218
- The Children's Hospital
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale-New Haven Children's Hospital
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Florida
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Miami, Florida, Estados Unidos, 33136
- Jackson Memorial Hospital
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University Of Iowa Hospitals And Clinics
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Missouri
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St. Louis, Missouri, Estados Unidos, 63104
- Saint Louis University - Department of Neurology and Psychiatry
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7221
- The University of North Carolina - CH
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Ohio
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Akron, Ohio, Estados Unidos, 44308
- Children's Hospital Medical Center of Akron
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Children's Medical Center
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hospital / Baylor College of Medicine
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Houston, Texas, Estados Unidos, 77030
- The University of Texas, Health Sciences Center at Houston
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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
4 semanas a 16 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Pediatric subjects aged 28 days to 16 years,
- Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),
- Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Exclusion Criteria:
- Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve,
- Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone,
- Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone.
Other protocol-specific inclusion/exclusion criteria may apply.
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
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: ≥ 28 Days to < 13 Months
infant and toddler
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Outros nomes:
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Experimental: ≥ 13 months to < 5 years
young child
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Outros nomes:
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Experimental: ≥ 5 years to < 12 years
older child
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Outros nomes:
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Experimental: ≥ 12 years to < 17 years
adolescent
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
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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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Prazo: A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
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Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only. |
A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
Prazo: Immediately prior to first oral dose, up to 54 hours
|
There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability.
Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10.
The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.
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Immediately prior to first oral dose, up to 54 hours
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Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time
Prazo: Immediately prior to first oral dose with potentially up to 54 hours duration.
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Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions.
Each face is 25 x 35 mm with 13 mm between faces.
Each subject was asked to point to the face that reflected his or her pain.
The end points are 0 = no pain and 10 = very much pain.
The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.
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Immediately prior to first oral dose with potentially up to 54 hours duration.
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Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time
Prazo: Immediately prior to first oral dose, up to 54 hours
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The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = "no pain" and 10 = "most pain," was used by children ≥ 12 years of age.
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Immediately prior to first oral dose, up to 54 hours
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Gregory B. Hammer, MD, Stanford University
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
1 de abril de 2007
Conclusão Primária (Real)
1 de maio de 2009
Conclusão do estudo (Real)
1 de abril de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de abril de 2007
Primeira postagem (Estimativa)
25 de abril de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de novembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de outubro de 2015
Última verificação
1 de outubro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HMP4009
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