Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

19 octobre 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

116

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

4 semaines à 16 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: ≥ 28 Days to < 13 Months
infant and toddler
Médicament: 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.
Autres noms:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Expérimental: ≥ 13 months to < 5 years
young child
Médicament: 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.
Autres noms:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Expérimental: ≥ 5 years to < 12 years
older child
Médicament: 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.
Autres noms:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.
Expérimental: ≥ 12 years to < 17 years
adolescent
Médicament: 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.
Autres noms:
  • Infants and todlers;
  • Young child;
  • Older child;
  • Adolescent.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Purdue Pharma LP

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2007

Achèvement primaire (Réel)

1 mai 2009

Achèvement de l'étude (Réel)

1 avril 2010

Dates d'inscription aux études

Première soumission

24 avril 2007

Première soumission répondant aux critères de contrôle qualité

24 avril 2007

Première publication (Estimation)

25 avril 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

18 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 octobre 2015

Dernière vérification

1 octobre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HMP4009

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner