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: 19.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863MedDRA version: 19.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2012-004359-35-BG
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 193
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. A female subject must have a negative 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 first dose of IMP. Subjects must
remain hospitalized until the End of Treatment Visit.
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 in the investigator's judgment. Obesity can be
determined based on appropriate BMI charts or tables; e.g., a 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 or subject is cognitively impaired
in the investigator's judgment such that they cannot comply with the
protocol.
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 prohibited 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.
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.;<br> Timepoint(s) of evaluation of this end point: EU: 24 hours<br> US: 12 hours<br>
- Secondary Outcome Measures
Name Time Method