A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery
- Conditions
- The management of acute postoperative pain in hospitalized paediatric patients.MedDRA version: 17.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865MedDRA version: 17.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2012-004359-35-SE
- Lead Sponsor
- Janssen Research & Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 168
1. Informed consent, and if applicable assent, given according to local regulations.
2. Male or female subject aged from birth to less than 18 years.
3. A female subject must be pre-menarchal, or surgically incapable of childbearing, or sexually abstinent, or if a female subject is sexually active, then she must be practicing an effective method of birth control (e.g., prescription hormonal contraceptives, intra-uterine devices used according to the product’s instruction, double-barrier methods) before trial entry and throughout the trial.
4. female subject must have a negative urine pregnancy test if aged 12 years or older, or is post-menarchal, or is sexually active.
5. Subject has undergone surgery (other than brain surgery or gastrointestinal surgery expected to affect the absorption of tapentadol [in the investigator’s judgment]) that, in the investigator’s opinion, would reliably produce moderate to severe pain requiring opioid treatment for at least 24 hours after allocation/randomization to IMP.
6. Subject has received post-operative morphine or hydromorphone by NCA/PCA, with or without a background infusion of the same opioid, according to standard of care prior to allocation/randomization to IMP and subject is expected to require this morphine or hydromorphone by NCA/PCA after starting IMP.
7. Subject is able to tolerate liquids at the time of allocation/randomization to IMP.
Are the trial subjects under 18? yes
Number of subjects for this age range: 168
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Subject, parent or the 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 family member of the employees or the investigator.
2. Subject has been previously exposed to tapentadol.
3. Subject has received an experimental drug or used an experimental medical device within 28 days before allocation/randomization to IMP, or within a period less than 10 times the drug’s half-life,
whichever is longer.
4. Subject has a history or current condition of any one of the following:
• Non-febrile seizure disorder.
• Epilepsy.
• Serotonin syndrome.
• 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.
5. Subject has a history or current condition of any one of the following:
• Moderate to severe renal or hepatic impairment.
• Abnormal pulmonary function or clinically relevant respiratory disease (e.g., acute or severe bronchial asthma, hypercapnia).
6. Subject has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, paralytic ileus) that in the opinion of the investigator may affect or compromise subject safety during the trial participation.
7. Subject has history of suicidal ideation or behavior.
8. Subject is obese, e.g., BMI above the 97th percentile for children based on the World Health Organization growth charts.
9. Subject has a clinically relevant history of hypersensitivity, allergy, or contraindication to the supplemental opioid analgesic medication or tapentadol, or the excipients, or naloxone.
10. Subject is not able to understand and comply with the protocol as appropriate for the age of the subject.
11. Subject has a history of alcohol and/or substance abuse in the investigator’s judgment based on subject’s history and physical examination.
12. Subject is taking forbidden concomitant medication.
13. Subject has received a long-acting opioid for the treatment of pain following surgery within 6 hours of allocation/randomization to IMP.
14. Subject has clinically relevant (in the investigator’s judgment) abnormal values for clinical chemistry or hematology (local laboratory sample taken after surgery).
A subject is excluded if the:
• Aspartate transaminase or alanine transaminase is >3-times upper limit of normal.
• Total bilirubin is >2-times upper limit of normal (except if the cause is due to Gilbert’s syndrome).
• Glomerular filtration rate <60 mL/min (calculated according to a formula that is appropriate for the respective age group).
15. Subject has:
• Clinically relevant abnormal ECG.
• Signs of pre-excitation syndrome.
• Brugada’s syndrome.
• QT or QTc interval >470 ms for children aged 6 years to less than 18 years old.
• QT or QTc interval >460 ms for children aged from birth to less than 6 years old.
16. Peri- or post-operative analgesia supplied by a continuous regional technique (i.e., nerve block) or subject controlled epidural analgesia that was terminated less than 6 hours before allocation/randomization to IMP.
17. Subject has post-operative clinically unstable systolic and diastolic blood pressure, heart rate, respiratory depression, or clinically unstable upper or lower airway conditions (in the investigator’s
judgment), or a satu
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used within the first 24 hours after first IMP intake.;Secondary Objective: To assess the efficacy of tapentadol oral solution using multiple subjective and objective measures of the subject’s response to treatment.;Primary end point(s): The total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used after first IMP intake.;Timepoint(s) of evaluation of this end point: EU: 24 hours<br>US: 12 hours
- Secondary Outcome Measures
Name Time Method