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

Primary Purpose

Pain, Postoperative, Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tapentadol (OS) Oral Solution
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Postoperative, Postoperative Pain, Tapentadol, NUCYNTA, CG5503, R331333, Pharmacokinetics, Postsurgical pain, Children, Adolescents

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parent(s) or the legal guardian(s) of the patient signed an informed consent document indicating that they understand the purpose of the study, the risks and benefits of the procedures required for the study and give permission for their child to participate in the study
  • Physical status rated as I or II on the American Society of Anesthesiologists (ASA) rating scale
  • Patient is alert, oriented, able to follow commands, able to understand the study requirements and procedures, and able to communicate intelligibly with the health care provider (taking into account his/her age)
  • As per investigator's medical evaluation, patient is able to drink and tolerate oral fluids and medication
  • Patient has a postoperative pain intensity score >=4 on the McGrath Color Analog Scale (CAS) as a result of a scheduled surgical procedure or if in the investigator's clinical judgment (ie, investigator judgment relying on standard of care rather than the McGrath CAS), the patient has a pain level that the standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment

Exclusion Criteria:

  • History of seizure disorder or epilepsy, or serotonin syndrome, or mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or severe traumatic brain injury within 15 years of screening, or any traumatic or hypoxic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness
  • Moderate to severe renal or hepatic impairment
  • Requires concomitant use of sedatives, other than those used during surgery
  • Has received dextromethorphan within 2 days before the scheduled study drug administration.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tapentadol Oral Solution (OS)

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic profile

Secondary Outcome Measures

number of patients with adverse events as a measure of safety and tolerability
Number of patients with adverse events as a measure of safety and tolerability

Full Information

First Posted
May 28, 2010
Last Updated
July 11, 2014
Sponsor
Janssen Research & Development, LLC
Collaborators
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01134536
Brief Title
Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
Official Title
Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Grünenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This is a multicenter, single-arm, open-label (all people involved know the identity of the intervention), single-dose study to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time), safety and tolerability of tapentadol 1 mg/kg oral solution (OS) in children aged from 6 to less than 18 years after scheduled surgical procedures that routinely produce acute, moderate to severe postsurgical pain. A screening phase, as per standard of care but not exceeding 30 days, will include the preoperative evaluation, the surgical procedure and its immediate post recovery, and will be followed by the open-label treatment phase and end-of-study assessments. Study drug administration will take place after the surgery has been completed, when the patient is alert, orientated, able to follow commands and complete the required postoperative procedures, and able to tolerate fluid and medication orally. Confinement to the study center for a patient will be as per standard of care, and will include the surgery, the entire 15-hour postdose evaluation period and the end-of-study evaluations. Children with a body weight less than 20 kg will be dosed with a single dose of tapentadol 4 mg/mL OS and children with a body weight of 20 kg or greater will be dosed with a single dose of tapentadol 20 mg/mL OS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Pain
Keywords
Pain, Postoperative, Postoperative Pain, Tapentadol, NUCYNTA, CG5503, R331333, Pharmacokinetics, Postsurgical pain, Children, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tapentadol Oral Solution (OS)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tapentadol (OS) Oral Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetic profile
Time Frame
15 hours after the dose
Secondary Outcome Measure Information:
Title
number of patients with adverse events as a measure of safety and tolerability
Time Frame
end of treatment (from 15 hours post treatment to discharge or early withdrawal)
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
Up to 15 hours post treatment on Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent(s) or the legal guardian(s) of the patient signed an informed consent document indicating that they understand the purpose of the study, the risks and benefits of the procedures required for the study and give permission for their child to participate in the study Physical status rated as I or II on the American Society of Anesthesiologists (ASA) rating scale Patient is alert, oriented, able to follow commands, able to understand the study requirements and procedures, and able to communicate intelligibly with the health care provider (taking into account his/her age) As per investigator's medical evaluation, patient is able to drink and tolerate oral fluids and medication Patient has a postoperative pain intensity score >=4 on the McGrath Color Analog Scale (CAS) as a result of a scheduled surgical procedure or if in the investigator's clinical judgment (ie, investigator judgment relying on standard of care rather than the McGrath CAS), the patient has a pain level that the standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment Exclusion Criteria: History of seizure disorder or epilepsy, or serotonin syndrome, or mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or severe traumatic brain injury within 15 years of screening, or any traumatic or hypoxic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness Moderate to severe renal or hepatic impairment Requires concomitant use of sedatives, other than those used during surgery Has received dextromethorphan within 2 days before the scheduled study drug administration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC C. Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Hamilton
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
City
F-75 730 Paris Cedex 15
Country
France
City
Rennes
Country
France
City
Madrid N/A
Country
Spain
City
Madrid
Country
Spain
City
Valladolid
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=837&filename=CR016891_CSR.pdf
Description
Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years

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

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