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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 ottobre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

116

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 4 settimane a 16 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ≥ 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.
Altri nomi:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Sperimentale: ≥ 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.
Altri nomi:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Sperimentale: ≥ 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.
Altri nomi:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Sperimentale: ≥ 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.
Altri nomi:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Purdue Pharma LP

Investigatori

  • Investigatore principale: Gregory B. Hammer, MD, Stanford University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2007

Completamento primario (Effettivo)

1 maggio 2009

Completamento dello studio (Effettivo)

1 aprile 2010

Date di iscrizione allo studio

Primo inviato

24 aprile 2007

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2007

Primo Inserito (Stima)

25 aprile 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 ottobre 2015

Ultimo verificato

1 ottobre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HMP4009

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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