Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old

Stopped early · Phase 2

Conditions studied: Moderate to Severe Acute Postoperative Pain

In brief

This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain. The trial will also evaluate the safety and tolerability of tapentadol oral solution in the population studied and the effect of tapentadol oral solution on pain.

Key facts

Study ID

NCT02221674

Run by

Grünenthal GmbH

People needed

40

Starts

2014-11-05

Expected to finish

2016-11-03

Last updated by the study team

2018-01-29

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 participants 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, participant has a sedation score that is not higher than 2 (moderately sedated) on the University of Michigan Sedation Scale with the exception of participants 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.

You may not qualify if…

• 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 participant, or participant'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 interventional clinical trial 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, i.e. brain contusion, stroke, transient ischemic attack, intracranial bleeding or hematoma, brain neoplasm.
• 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 that in the opinion of the investigator would put the participant at risk for developing respiratory depression, unless the participant 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 (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 participant'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 in the investigator's judgment.
• Signs of pre-excitation syndrome.
• Corrected QT (QTcF) interval greater than 460 ms. Participant may be allocated to Investigational Medicinal Product with values greater than 460 ms if, in the investigator's opinion, the value is a consequence of cardiac surgery and is not considered clinically significant.

Where it is running

• US001 — Palo Alto, California, United States
• US002 — Louisville, Kentucky, United States
• US006 — Durham, North Carolina, United States
• US004 — Philadelphia, Pennsylvania, United States
• PL001 — Lodz, Poland
• PL004 — Torun, Poland
• GB001 — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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