- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01322204
Codeine in Mechanically Ventilated Neonates
Absorption and Metabolism of Oral Codeine in Mechanically Ventilated Neonates
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This proposal has its origins in a larger initiative to elucidate the pharmacological basis for the interindividual differences observed in opioid responsiveness. Gaps in our knowledge related to opioid disposition in newborns need to be addressed to complete the design of the required overarching initiative in which age could be treated as a continuous variable within a context of PK, PD and PG determinants.This proposal is designed to generate preliminary data that addresses two issues. First, can newborns absorb enterally administered codeine and is this ability determined by PCA or PNA age? The second relates to the ability of newborn infants to catalyze those reactions required to metabolically activate both codeine and morphine. The latter will also be evaluated within the context of PCA versus PNA age.
These data will not only fill an information gap that must be addressed before the larger initiative moves forward, but they also provide a platform for serious study of the ontogeny of certain pharmacokinetic processes that may prove critical to our understanding of newborn drug disposition. In this way, codeine can provide important insights concerning the ontogeny of drug disposition and permit the determination of the relative importance of PCA versus PNA ages to the functional expression of these processes.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Brooklyn, New York, Forente stater, 11203
- State University of New York Downstate
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Neonates ≥ 26 weeks PCA receiving mechanical ventilation and painful procedure will be eligible for participation in the study
- Subject's parent/legal guardian must give written informed consent prior to study participation
- Subject is receiving opioid analgesia therapy based on caregiver determination. The ideal patient will not be receiving morphine.
- Must be able to receive an enteral dose of codeine.
Exclusion Criteria:
- Known hypersensitivity to morphine, fentanyl, or codeine
- Patients with ALT concentrations >2x upper limit of normal for age or clinical evidence of hepatic failure
- Patients with serum creatinine concentrations >2x upper limit of normal for age or clinical evidence of renal failure
- Patients who are NPO
- Babies born to maternal drug abuse.
- Total serum bilirubin level of > 10 mg/dl or 170 umol/L.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
Neonates 0-30 days, no more than 2,000 grams, receiving mechanical ventilation.
|
One single oral dose of 1 mg/kg of codeine
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The rate and extent of absorption of oral codeine, the ratios of the observed concentration of each metabolite to the observed concentration of parent drug and the formation and clearances of the metabolites.
Tidsramme: 2 hours
|
2 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Secondary outcomes include the additional PK parameters elimination half life, area under the curve and mean residence time.
Tidsramme: 2 hours
|
2 hours
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jacob V Aranda, MD, PhD, State University of New York Downstate
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10922
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