Open-label investigation of the pharmacokinetic profile, safety, tolerability, and efficacy of multiple administrations of tapentadol oralsolution used for treatment of acute pain in children aged 2 years to less than 7 years

Grünenthal GmbH0 sites15 target enrollmentJune 28, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 28, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Informed consent, and if applicable assent, given according to local regulations.
•\- The subject is male or female and aged 2 years to less than 7 years from the time of allocation to investigational medicinal product (IMP) until End of Treatment and Evaluation Visit (Visit 3\).
•\- The subject experienced a painful event (e.g., a painful intervention or surgery) that, in the investigator’s opinion, would reliably produce acute pain requiring treatment with a strong analgesic (e.g., opioids or metamizole) for at least 24 hours after Dose 1\. The subject is expected to remain hospitalized until Visit 3\.
•\- The subject is able to tolerate liquids at the time of allocation to IMP.
•\- The subject has a reliable venous vascular access or can be venipunctured repeatedly for pharmacokinetic blood sampling, depending on which is less burdensome for the individual subject.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 15
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•\- The subject, their parent, or their legal representative is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or is a family member of the employees or the investigator.
•\- The subject has been exposed to tapentadol 28 days or less before enrollment.
•\- The subject has received an experimental drug 28 days or less before allocation to IMP or, if 10 half\-lives of the drug are longer than 28 days, 10 half\-lives of the drug or less before allocation to IMP.
•\- The subject participates concurrently in another clinical trial with an experimental drug.
•\- The subject has undergone brain surgery.
•\- The subject has undergone an intervention or surgery that will, in the opinion of the investigator, affect the absorption of tapentadol (e.g., surgery of the gastrointestinal tract).
•\- The subject has signs or symptoms of congestive heart failure (e.g., requiring more than minimal inotropic support), or hemorrhagic disorder following surgery.
•\- The subject has (a history of) any of the following:
•Seizure disorder or epilepsy.
•Renal or hepatic impairment.