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An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain (Palladone)

19 de octubre de 2015 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

116

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

  • Estados Unidos
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72202
        • Arkansas Children's Hospital
    • California
      • Orange, California, Estados Unidos, 92868
        • Children's Hospital of Orange County - Pediatric Subspecialty
      • Stanford, California, Estados Unidos, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80218
        • The Children's Hospital
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale-New Haven Children's Hospital
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • Jackson Memorial Hospital
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • University of Iowa Hospitals and Clinics
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63104
        • Saint Louis University - Department of Neurology and Psychiatry
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7221
        • The University of North Carolina - CH
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center
    • Ohio
      • Akron, Ohio, Estados Unidos, 44308
        • Children's Hospital Medical Center of Akron
    • Texas
      • Dallas, Texas, Estados Unidos, 75235
        • Children's Medical Center
      • Houston, Texas, Estados Unidos, 77030
        • Texas Children's Hospital / Baylor College of Medicine
      • Houston, Texas, Estados Unidos, 77030
        • The University of Texas, Health Sciences Center at Houston

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

4 semanas a 16 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

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
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ≥ 28 Days to < 13 Months
infant and toddler
Droga: Hydromorphone
Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Otros nombres:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Experimental: ≥ 13 months to < 5 years
young child
Droga: Hydromorphone
Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Otros nombres:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Experimental: ≥ 5 years to < 12 years
older child
Droga: Hydromorphone
Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Otros nombres:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Experimental: ≥ 12 years to < 17 years
adolescent
Droga: Hydromorphone
Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Otros nombres:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Periodo de tiempo: A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.

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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
Periodo de tiempo: 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.
Immediately prior to first oral dose, up to 54 hours
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time
Periodo de tiempo: Immediately prior to first oral dose with potentially up to 54 hours duration.
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.
Immediately prior to first oral dose with potentially up to 54 hours duration.
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time
Periodo de tiempo: Immediately prior to first oral dose, up to 54 hours
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.
Immediately prior to first oral dose, up to 54 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Purdue Pharma LP

Investigadores

  • Investigador principal: Gregory B. Hammer, MD, Stanford University

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

1 de abril de 2007

Finalización primaria (Actual)

1 de mayo de 2009

Finalización del estudio (Actual)

1 de abril de 2010

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2007

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2007

Publicado por primera vez (Estimar)

25 de abril de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de noviembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

19 de octubre de 2015

Última verificación

1 de octubre de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HMP4009

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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