An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain (Palladone)
19 oktober 2015 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
116
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72202
- Arkansas Children's Hospital
-
-
California
-
Orange, California, Förenta staterna, 92868
- Children's Hospital of Orange County - Pediatric Subspecialty
-
Stanford, California, Förenta staterna, 94305
- Stanford University Medical Center
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80218
- The Children's Hospital
-
-
Connecticut
-
New Haven, Connecticut, Förenta staterna, 06510
- Yale-New Haven Children's Hospital
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- Jackson Memorial Hospital
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa Hospitals and Clinics
-
-
Missouri
-
St. Louis, Missouri, Förenta staterna, 63104
- Saint Louis University - Department of Neurology and Psychiatry
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599-7221
- The University of North Carolina - CH
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44308
- Children's Hospital Medical Center of Akron
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75235
- Children's Medical Center
-
Houston, Texas, Förenta staterna, 77030
- Texas Children's Hospital / Baylor College of Medicine
-
Houston, Texas, Förenta staterna, 77030
- The University of Texas, Health Sciences Center at Houston
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 veckor till 16 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ≥ 28 Days to < 13 Months
infant and toddler
|
Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Andra namn:
|
|
Experimentell: ≥ 13 months to < 5 years
young child
|
Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Andra namn:
|
|
Experimentell: ≥ 5 years to < 12 years
older child
|
Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Andra namn:
|
|
Experimentell: ≥ 12 years to < 17 years
adolescent
|
Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Gregory B. Hammer, MD, Stanford University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2007
Primärt slutförande (Faktisk)
1 maj 2009
Avslutad studie (Faktisk)
1 april 2010
Studieregistreringsdatum
Först inskickad
24 april 2007
Först inskickad som uppfyllde QC-kriterierna
24 april 2007
Första postat (Uppskatta)
25 april 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 november 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 oktober 2015
Senast verifierad
1 oktober 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HMP4009
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .