Moderate to severe acute post-operative pain.
Conditions
Interventions
Trade Name: Palexia 4 mg/mL Lösung zum Einnehmen
Product Name: Tapentadol 4 mg/mL Oral Solution
Product Code: CG5503
Pharmaceutical Form: Oral solution
INN or Proposed INN: Tapentadol
CAS Number: 1755
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The participant's parent(s) or legal guardian(s) have given written informed consent to participate. • Participant is not obese (e.g., a body weight above the 97th percentile for children based on the World Health Organization weight charts) with a minimum body weight of 2.5 kg. • Physical status rated not higher than P3 on the American Society of Anesthesiologists physical status classification in subjects aged from 1 month to less than 2 years. • Participant has undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment. • At the time of allocation to study medication, particiapnt has a sedation score that is not higher than 2 (moderately sedated) on the University of Michigan Sedation Scale and subject is able to tolerate oral medication and oral fluids. • Participant has a reliable venous vascular access for pharmacokinetic blood sampling. 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 participant's parent(s) or legal guardian(s) is an employee of the investigator or trial site, with direct involvement in this trial or other trials under the direction of that investigator or trial site, or the subject, or subject's parent(s), or legal guardian(s) is a family member of the employees or the investigator. • Participant has been previously exposed to tapentadol. • Participant has received an experimental drug or used an experimental medical device within 28 days before allocation to study medication, or within a period less than 10 times the drug's half-life, whichever is longer. • Concomitant participation in another clinical trial with an experimental drug or experimental device for the duration of this trial. • Participant has undergone brain surgery. • Participant has undergone a surgery that is expected to affect the absorption of tapentadol (e.g., to the gastrointestinal tract). • Participant has a history or current condition of any one of the following: - Seizure disorder. - Traumatic or hypoxic brain injury, brain contusion, stroke, transient ischemic attack, intracranial hematoma, post-traumatic amnesia, brain neoplasm, or episode(s) of unconsciousness of more than 24 hours. • Participant has a history or current condition of any one of the following: - Moderate to severe renal impairment. - Moderate to severe hepatic impairment, congestive hepatopathy, or hepatic portosystemic shunting. - Clinically relevant abnormal pulmonary function or clinically relevant respiratory disease. • Participant has signs or symptoms of congestive heart failure (e.g., requiring more than minimal inotropic support, an abnormal lactic acid value greater than 2-times upper limit of normal), or hemorrhagic disorder following surgery. • Minimal inotropic medication is defined as: - Dopamine less or equal to 5 microgram/kg per minute. - Epinephrine less or equal to 0.03 microgram/kg per minute (but not both dopamine and epinephrine). - Milrinone less or equal to 0.5 microgram/kg per minute or less. • Participant has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, or psychiatric disorder, or a febrile seizure or paralytic ileus) that in the opinion of the investigator may affect or compromise participant's safety during the trial participation. • Participant has cognitive or developmental impairment such that trial participation may affect or compromise the participant's safety, or the participant's ability to comply with the protocol requirements (as appropriate for the subject's age), in the investigator's judgment. Otherwise, participant's with cognitive or developmental impairment may be enrolled in the trial. • Participant has a clinically relevant history of hypersensitivity, allergy, or contraindication to tapentadol (or ingredients). Participant has: • Clinically relevant abnormal 12-lead ECG. • Signs of pre-excitation syndrome. • Corrected QT (QTcF) interval >460 ms. Subjects may be allocated to IMP with values >460 ms if, in the investigator’s opinion, the value is a consequence of cardiac surgery and is not considered clinically significant. • Participant has clinically relevant abnormal lab values from a sample obtained postoperatively and prior to allocation to study medication. The following specifications will apply: - Aspartate transaminase or alanine transaminase is greater than 2.5-times upper limit of normal. - Total bilirubin is greater than 2-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide after the administration of a single dose of tapentadol oral solution in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain requiring opioid treatment. The concentration data will be used to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach. This will enable data based recommendations for the use of tapentadol in children of different ages (birth to less than 1 month, 1 month to less than 6 months, and 6 months to less than 2 years) in subsequent safety and efficacy trials.;Secondary Objective: To evaluate the safety and tolerability of tapentadol oral solution in the population studied. To explore the effect of tapentadol oral solution on moderate to severe pain that, in the opinion of the investigator, requires treatment with an opioid.;Primary end point(s): Pharmacokinetic evaluation based on serum concentrations of tapentadol and tapentadol-O-glucuronide obtained from blood samples.;Timepoint(s) of evaluation of this end point: Within 8 hours of study medication intake at 2 time points per participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Poland, United Kingdom, United States
Contacts
Public ContactGrünenthal Trial Information Desk
Grünenthal GmbH
Outcome results
None listed