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.
Brief Title
Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pain, Postoperative
Postoperative Pain
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Pain, Postoperative
Postoperative Pain
Tapentadol
NUCYNTA
CG5503
R331333
Pharmacokinetics
Postsurgical pain
Children
Adolescents
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
6 Years
NCT Id
NCT01134536
Org Class
Industry
Org Full Name
Janssen Research & Development, LLC
Org Study Id
CR016891
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Pharmacokinetic profile
Outcome Time Frame
15 hours after the dose
Secondary Ids
Secondary Id
R331333PAI2005
Secondary Id
KF59
Secondary Id
2010-020380-20
Secondary Id
KF5503/59
Secondary Outcomes
Outcome Time Frame
end of treatment (from 15 hours post treatment to discharge or early withdrawal)
Outcome Measure
number of patients with adverse events as a measure of safety and tolerability
Outcome Time Frame
Up to 15 hours post treatment on Day 1
Outcome Measure
Number of patients with adverse events as a measure of safety and tolerability
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
6
Investigators
Investigator Type
Principal Investigator
Investigator Name
Veronica Carullo
Investigator Email
vcarullo@montefiore.org
Investigator Phone