NCT01586507

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2012-04-26
• Last updated: 2012-08-29