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Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents

NCT01134536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-07-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.

Conditions

  • Pain, Postoperative
  • Postoperative Pain

Interventions

DRUG

Tapentadol (OS) Oral Solution

Tapentadol OS Bodyweight \<20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight \>=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.

Sponsors & Collaborators

  • Grünenthal GmbH

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Canada
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134536 on ClinicalTrials.gov