Moderate to severe acute pain MedDRA version: 20.1 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Palexia 4 mg/ml oral solution
Product Name: Palexia 4 mg/ml oral solution
Pharmaceutical Form: Oral solution
INN or Proposed INN: Tapentadol
CAS Number: 175591-09-0
Other descriptive name:
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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. • Acute or severe bronchial asthma or hypercapnia. • Brain tumors, clinically relevant history or a current condition of head injury, or increased intracranial pressure including traumatic and hypoxic brain injuries such as stroke, transient ischemic attack, brain contusion, intracranial hematoma, episode(s) of more than 24 hours duration of unconsciousness, or posttraumatic amnesia. - The subject has biliary tract disease or has or is suspected of having paralytic ileus. - The subject has a disease or disorder (e.g., impaired respiratory function or clinically relevant respiratory disease, endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, clinically relevant abnormal electrocardiogram [ECG]) that, in the opinion of the investigator, may affect or compromise the subject’s safety during participation in the trial. - The subject is obese, i.e., has a body mass index (BMI) equal to or above the 95th percentile for children based on the World Health Organization (WHO) BMI charts. - The subject has a body weight below 9.0 kg. - The subject has a clinically relevant history of hypersensitivity, allergy, or contraindication to tapentadol, or the excipients (see the summary of product characteristics [SmPC]), or naloxone. - The subject is mentally retarded, cognitively impaired, or unable to comprehensively understand or follow the trial instructions as appropriate for the age of the subject, based on medical history and/or in the judgment of the investigator. - The subject is taking prohibited concomitant medication. - The subject will be excluded if any of the following criteria applies for local safety laboratory results: • Aspartate transaminase and/or alanine transaminase is above 3 times upper limit of normal. • Total bilirubin is above 2 times upper limit of normal. • Glomerular filtration rate (GFR) is below 60 mL/min (calculated according to Schwartz et al. 1984). • Lactic acid value is above 2 times upper limit of normal (only if the painful event was cardiac surgery). • Any other parameter is, in the judgment of the investigator, clinically significant and would put the subject at undue risk if they were to take part in the trial. - The subject will be excluded if any of the following criteria is met at the time of allocation to IMP: • The subject has,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetic profile of tapentadol after the administration of multiple doses of tapentadol oral solution to children aged 2 years to less than 7 years after a painful event that routinely produces acute pain requiring treatment with a strong analgesic medication (e.g., opioids or metamizole).;Secondary Objective: To investigate the pharmacokinetic profile of tapentadol-O-glucuronide after the administration of multiple doses of tapentadol oral solution to children aged 2 years to less than 7 years after a painful event that routinely produces acute pain requiring treatment with a strong analgesic medication (e.g., opioids or metamizole). To investigate the pharmacokinetic profile of tapentadol-O-sulphate after the administration of multiple doses of tapentadol oral solution to children aged 2 years to less than 7 years after a painful event that routinely produces acute pain requiring treatment with a strong analgesic medication (e.g., opioids or metamizole).;Primary end point(s): Area under the concentration-time curve at steady state for the dosing interval (AUCtau,SS) for tapentadol;Timepoint(s) of evaluation of this end point: From 1.5 hours after Dose 1 (Day 1) until 10 hours after the final dose (Day 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Area under the concentration-time curve at steady state for the dosing interval (AUCtau,SS) for tapentadol-O-glucuronide Area under the concentration-time curve at steady state for the dosing interval (AUCtau,SS) for tapentadol-O-sulphate;Timepoint(s) of evaluation of this end point: From 1.5 hours after Dose 1 (Day 1) until 10 hours after the final dose (Day 4) | — |
Countries
Poland
Contacts
Public ContactGrünenthal Trial Information Desk
Grünenthal GmbH
Outcome results
None listed