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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 oktober 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

116

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

4 weken tot 16 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ≥ 28 Days to < 13 Months
infant and toddler
Geneesmiddel: 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.
Andere namen:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Experimenteel: ≥ 13 months to < 5 years
young child
Geneesmiddel: 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.
Andere namen:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Experimenteel: ≥ 5 years to < 12 years
older child
Geneesmiddel: 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.
Andere namen:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Experimenteel: ≥ 12 years to < 17 years
adolescent
Geneesmiddel: 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.
Andere namen:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Purdue Pharma LP

Onderzoekers

  • Hoofdonderzoeker: Gregory B. Hammer, MD, Stanford University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2007

Primaire voltooiing (Werkelijk)

1 mei 2009

Studie voltooiing (Werkelijk)

1 april 2010

Studieregistratiedata

Eerst ingediend

24 april 2007

Eerst ingediend dat voldeed aan de QC-criteria

24 april 2007

Eerst geplaatst (Schatting)

25 april 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

18 november 2015

Laatste update ingediend die voldeed aan QC-criteria

19 oktober 2015

Laatst geverifieerd

1 oktober 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HMP4009

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