A study to look at Tapentadol Tablets in Children and Adolescents in pain.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 69

Inclusion Criteria

Subjects are eligible for the trial at if all the following apply:
1. Informed consent/(if applicable) assent obtained.
2. Male or female subject at least 6 years of age at the Enrollment Visit and less than 18 years of age on the predicted day of Visit VE.
3. Subject has an underlying long-term pain condition that is, according to the judgment of the investigator, expected to require a twice-daily prolonged release opioid treatment until at least the end of the 14-day Treatment Period (Visit VE).
4. Subject can swallow tablets of appropriate size.
5. Subject is able to participate in the trial as planned and willing to comply with the requirements of the protocol including refraining from drinking beverages containing alcohol and recreational intake of drugs while on IMP.

Subjects must satisfy the following criteria at Visit V2:
6. Less than 18 years of age on the planned day of Visit VE.
7. No opioid intake or last calculated morphine equivalent dose at day of allocation of less than 3.5 mg/kg per day.
8. Subject has a body weight of at least 17.5 kg.
9. If a female of childbearing potential (post menarchal and not surgically incapable of childbearing) and sexually active, must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch) before allocation to IMP until the end of intake of IMP.
10. If a female and post menarchal or older than 12 years, has a negative urine pregnancy test on the day before or on the day of allocation to IMP.

Inclusion criteria for the Tapentadol Period (Part 2):
17. Subject has completed the 14-day Treatment Period.
18. Subject is still in need of prolonged release opioid treatment.
19. Subject does not meet any of the compulsory discontinuation criteria (described in Section 9.3.1 of the body of the protocol).

Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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

Subjects are not eligible for the trial if any of the following apply:
The following will be checked at Visit V1:
1. Has been previously enrolled in this trial or a previous trial with tapentadol.
2. Has a clinically relevant history of hypersensitivity, allergy, or contraindication to morphine or tapentadol or any ingredient, including galactose intolerance (see investigator’s brochure for tapentadol PR and summary of product characteristics for morphine PR), or naloxone.
3. History or current condition of any one of the following:
• Seizure disorder or epilepsy.
• Serotonin syndrome.
• Traumatic or hypoxic brain injury, brain contusion, stroke, transient ischemic attack, intracranial hematoma, posttraumatic amnesia, brain neoplasm, or episode(s) of more than 24 hours duration of unconsciousness.
4. 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).
• Complex regional pain syndrome.
• A pain indication with a strong psycho-somatic component that, in the judgment of the investigator, is unlikely to respond to opioids.
5. History of alcohol or drug abuse in the investigator’s judgment, based on history and physical examination. Drugs of abuse detected in urine screen unless explained by allowed concomitant medication.
6. Subject has:
• A clinically relevant abnormal ECG.
• Signs of pre-excitation syndrome.
• Brugada’s syndrome.
• QT or QTcF (Fridericia) interval greater than 470 ms.
7. Any surgery scheduled during Part 1 of the trial that is expected to require post-surgical intensive care unit (ICU) treatment, or that requires post–surgical parenteral pain-treatment, or may, in the opinion of the investigator, affect the safety of the subject.
8. 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.
9. Subject, parent or the legal representative is an employee of the investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial site, or family member of the employees or the investigator.

The following will be checked at Visit V1 and Visit V2:
10. Has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection) that in the opinion of the investigator may affect or compromise subject safety during the trial participation.
11. Pancreatic/biliary tract disease (e.g., pancreatitis) or paralytic ileus.
12. Intake of forbidden concomitant medication/use of forbidden therapies.
13. Female subject breast-feeding a child.

The following will be checked at Visit V2:
14. Has received a drug or used a medical device not approved for human use within 30 days prior to Vis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 11/12/2018

A study to look at Tapentadol Tablets in Children and Adolescents in pain.

Recruitment & Eligibility

Study & Design

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