A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain
28 augusti 2012 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
38
Fas
- Fas 1
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
12 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Grupp 2
|
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.
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.
|
|
Experimentell: Grupp 1
|
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The area under the curve (AUC∞) of ULTRAM ER as the primary PK parameter
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Plasma concentration profile of ULTRAM ER
Tidsram: 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
Tidsram: 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
Tidsram: 48 hours post dose
|
48 hours post dose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 oktober 2007
Primärt slutförande (Faktisk)
1 september 2008
Avslutad studie (Faktisk)
1 september 2008
Studieregistreringsdatum
Först inskickad
25 april 2012
Först inskickad som uppfyllde QC-kriterierna
25 april 2012
Första postat (Uppskatta)
26 april 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 augusti 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 augusti 2012
Senast verifierad
1 augusti 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR014017
- TRAMAPPAI1003 (Annan identifierare: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
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 .
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