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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Tramadol

Criteria

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