A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain

NCT01586494 | Completed Phase 1

• 2 other identifiers: CR014014TRAMAPPAI1002
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old, inclusive (up to 11 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.

Conditions

Pain

Keywords

Pain; ULTRAM ER; Tramadol hydrochloride; Children

Outcome Measures

Primary Outcomes (1)

• The area under the curve (AUC∞) of ULTRAM ER as the primary PK parameter

  At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose

Secondary Outcomes (3)

• Plasma concentration profile of ULTRAM ER

  At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose

• Plasma concentration profiles of M1 and M5 metabolites

  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

  48 hours post dose

Study Arms (2)

Group 1

EXPERIMENTAL

Drug: ULTRAM ER

Group 2

EXPERIMENTAL

Drug: ULTRAM ER

Interventions

ULTRAM ER DRUG

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.

Group 1

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 20 kg
• Female participants must be premenarchal and in the opinion of the investigator not sexually active
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 26, 2012
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 29, 2012

Record last verified: 2012-08