A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery

Phase 1

• 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: 100000004863; MedDRA version: 19.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2012-004359-35-HU
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 193

Inclusion Criteria

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

Exclusion Criteria

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.
• 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 Schwartz et al. 1984).
15. Subject has:
• Clinically relevant abnormal ECG.
• Signs of pre-excitation syndrome.
• Brugada's syndrome.

Study & Design

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