se of tapentadol oral solution for pain after surgery in children from newborn to less than 2 years old.

Phase 1

• Conditions: Moderate to severe acute post-operative pain.; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2014-000623-24-PL
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-22
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• The participant's parent(s) or legal guardian(s) have given written informed consent to participate.
• Male or female subject aged from birth (=37 weeks gestational age) to less
than 2 years.
• 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 IMP, subject has a sedation score that is not higher
than 2 (moderately sedated) on the University of Michigan Sedation Scale
with the exception of subjects who are mechanically ventilated in age
subgroup 3 , has a functioning gastrointestinal tract after surgery, and can
tolerate medication administered orally or via a feeding tube at the time of
allocation to IMP.
• 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

• The participant's parent(s)/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/trial site/the subject/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).
• Subject has a history or current condition of any one of the following:
• Seizure disorder.
• Traumatic or hypoxic brain injury, i.e., brain contusion, stroke, transient ischemic attack, intracranial bleeding or hematoma, brain neoplasm.
• Subject 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 that in the opinion of the investigator would put the
subject at risk for developing respiratory depression, unless the subject is mechanically ventilated in age subgroup 3.
• 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 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.
• Subject has clinically relevant abnormal laboratory values from a sample obtained post-operatively and prior to allocation to IMP. The following specifications will apply:
• Aspartate transaminase or alanine transaminase is >2.5-times upper limit of normal.
• Total bilirubin is >2-times upper limit of normal and direct bilirubin >20% of the total bilirubin, and for subj

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified