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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

116

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 uker til 16 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ≥ 28 Days to < 13 Months
infant and toddler
Legemiddel: 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.
Andre navn:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Eksperimentell: ≥ 13 months to < 5 years
young child
Legemiddel: 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.
Andre navn:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Eksperimentell: ≥ 5 years to < 12 years
older child
Legemiddel: 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.
Andre navn:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Eksperimentell: ≥ 12 years to < 17 years
adolescent
Legemiddel: 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.
Andre navn:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Tidsramme: 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.

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Purdue Pharma LP

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2007

Primær fullføring (Faktiske)

1. mai 2009

Studiet fullført (Faktiske)

1. april 2010

Datoer for studieregistrering

Først innsendt

24. april 2007

Først innsendt som oppfylte QC-kriteriene

24. april 2007

Først lagt ut (Anslag)

25. april 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. november 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. oktober 2015

Sist bekreftet

1. oktober 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HMP4009

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