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

NCT ID: NCT01134536

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-03-31

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.

Conditions

Pain, Postoperative; Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapentadol Oral Solution (OS)

Group Type: EXPERIMENTAL

Tapentadol (OS) Oral Solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC C. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Little Rock, Arkansas, United States

Washington D.C., District of Columbia, United States

Meridian, Idaho, United States

Ann Arbor, Michigan, United States

The Bronx, New York, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Toledo, Ohio, United States

Pittsburgh, Pennsylvania, United States

Salt Lake City, Utah, United States

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Sherbrooke, Quebec, Canada

F-75 730 Paris Cedex 15, , France

Rennes, , France

Madrid, , Spain

Valladolid, , Spain

Countries

United States; Canada; France; Spain

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=837&filename=CR016891_CSR.pdf

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

Other Identifiers

R331333PAI2005

Identifier Type: OTHER

Identifier Source: secondary_id

KF59

Identifier Type: OTHER

Identifier Source: secondary_id

2010-020380-20

Identifier Type: OTHER

Identifier Source: secondary_id

KF5503/59

Identifier Type: OTHER

Identifier Source: secondary_id

CR016891

Identifier Type: -

Identifier Source: org_study_id