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More info
You can access this
clinical trial
if you have
Pain
and you are
between 12 and 17
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: ULTRAM ER
  • Drug: ULTRAM ER

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01586507. The sponsor of the trial is Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and it is looking for 38 volunteers for the current phase.
Official trial title:
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