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A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain

28. august 2012 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Single Dose Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER at Two Dose Levels in Adolescents Twelve to Seventeen Years Old, Inclusive, With Pain

The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old, inclusive (up to 17 years 364 days) with pain due to injury or nonmalignant disease, to the PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multicenter, open-label (all people know the identity of the intervention), 2-group, single dose study. Within each group of participants for Parts 1 and 2, at least 1/3 of the participants will be female, at least 1/3 of the participants will be male, at least 1/3 of the participants will be below the age of 14 years, and at least 1/3 of the participants will be above the age of 16 years. Participants will be assigned to 1 group only. Each group of participants will receive a single oral dose of ULTRAM ER on 1 occasion. Group 1 will receive a dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments. Following completion of all evaluations of Group 1, the pharmacokinetic data will be evaluated to target a dose for Group 2 that will achieve a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults. The maximum dose of ULTRAM ER should not exceed 6 mg/kg or 300 mg. When the study physician, the investigators, and the medical monitors agree that the PK of the drug is well-characterized and that the drug is well tolerated, enrollment will begin for Group 2 of the study. The sponsor's responsible Medical Officer will evaluate the safety of the calculated dose in Group 2 participants by evaluation of adverse drug events paying particular attention to events suggestive of either opioid toxicity or serotonin toxicity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Fase 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Confirmed need for control of pain due to injury or nonmalignant disease that does not influence fluid shifts and general drug disposition
  • Weighs at least 30 kg
  • Female participants must be premenarchal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control
  • Able to swallow the intact tablet with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
  • Signed informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study
  • Informed consent signed by the parent(s) or the legal guardian(s) of the participant

Exclusion Criteria:

  • History of or current clinically significant medical illness or condition including (but not limited to) cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe 2
Medicin: ULTRAM ER
One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.
Medicin: ULTRAM ER
The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.
Eksperimentel: Gruppe 1
Medicin: ULTRAM ER
One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.
Medicin: ULTRAM ER
The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The area under the curve (AUC∞) of ULTRAM ER as the primary PK parameter
Tidsramme: At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose
At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose

Sekundære resultatmål

Resultatmål
Tidsramme
Plasma concentration profile of ULTRAM ER
Tidsramme: At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose
At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose
Plasma concentration profiles of M1 and M5 metabolites
Tidsramme: At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose
At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose
Incidence of adverse events as a measure of safety and tolerability
Tidsramme: 48 hours post dose
48 hours post dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Efterforskere

  • Studieleder: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

25. april 2012

Først indsendt, der opfyldte QC-kriterier

25. april 2012

Først opslået (Skøn)

26. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR014017
  • TRAMAPPAI1003 (Anden identifikator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med ULTRAM ER

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CROs in Zambia

Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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