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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01134536

Collaborator

Grünenthal GmbH (Industry)

Enrollment

Locations

Arm

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Postoperative Pain	Drug: Tapentadol (OS) Oral Solution	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tapentadol Oral Solution (OS)	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.

Arm

Intervention/Treatment

Experimental: Tapentadol Oral Solution (OS)

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.

Outcome Measures

Primary Outcome Measures

Pharmacokinetic profile [15 hours after the dose]

Secondary Outcome Measures

number of patients with adverse events as a measure of safety and tolerability [end of treatment (from 15 hours post treatment to discharge or early withdrawal)]
Number of patients with adverse events as a measure of safety and tolerability [Up to 15 hours post treatment on Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	City	State	Country
1	Little Rock	Arkansas	United States
2	Washington	District of Columbia	United States
3	Meridian	Idaho	United States
4	Ann Arbor	Michigan	United States
5	Bronx	New York	United States
6	Charlotte	North Carolina	United States
7	Durham	North Carolina	United States
8	Toledo	Ohio	United States
9	Pittsburgh	Pennsylvania	United States
10	Salt Lake City	Utah	United States
11	Hamilton	Ontario	Canada
12	Ottawa	Ontario	Canada
13	Sherbrooke	Quebec	Canada
14	F-75 730 Paris Cedex 15		France
15	Rennes		France
16	Madrid N/A		Spain
17	Madrid		Spain
18	Valladolid		Spain