Clinical trial NCT01134536: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Postoperative Pain
Keywords: Pain, Postoperative
Postoperative Pain
Tapentadol
NUCYNTA
CG5503
R331333
Pharmacokinetics
Postsurgical pain
Children
Adolescents
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Grünenthal GmbH
First posted: 2010-06-02
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetic profile
timeFrame: 15 hours after the dose
Secondary outcomes:
measure: number of patients with adverse events as a measure of safety and tolerability
timeFrame: end of treatment (from 15 hours post treatment to discharge or early withdrawal)
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: Up to 15 hours post treatment on Day 1
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Washington
country: United States
state: District of Columbia
city: Meridian
country: United States
state: Idaho
city: Ann Arbor
country: United States
state: Michigan
city: Bronx
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC C. Clinical Trial
role: STUDY_DIRECTOR
References: