Last updated on October 2017

An Open-label Trial Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR Followed by an Open-label Extension.


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pain
  • Age: Between 6 - 17 Years
  • Gender: Male or Female
  • Other:
    Part 1 - Randomized to open-label, active comparator controlled treatment
    Participants are eligible for the trial at if all the following apply:
    Informed consent (if applicable assent) obtained.
    Male or female participant at least 6 years of age at the Enrollment Visit and less
    than 18 years of age on Day 14.
    Participant 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.
    Participant can swallow tablets of appropriate size.
    Participant 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 study medication.
    Participants must satisfy the following criteria before allocation to treatment:
    Less than 18 years of age.
    No opioid intake or last calculated morphine equivalent dose of less than 3.5 mg/kg
    per day.
    Participant has a body weight of at least 17.5 kg.
    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 study
    medication until the end of intake of study medication.
    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 study medication.
    Part 2
    Participant has completed the 14-day Treatment Period.
    Participant is still in need of prolonged release opioid treatment.
    Participant does not meet any of the compulsory discontinuation criteria.

You may not be eligible for this study if the following are true:

  • Participants are not eligible for the trial if any of the following apply.
    The following will be checked at enrollment:
    Has been previously enrolled in this trial or a previous trial with tapentadol.
    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.
    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.
    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)
    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
    Participant has:
    A clinically relevant abnormal electrocardiogram.
    Signs of pre-excitation syndrome.
    Brugada's syndrome.
    QT or QTcF (Fridericia) interval greater than 470 ms.
    Any surgery scheduled during the first 14 days 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, affect the safety of the participant.
    Participant 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.
    Participant, 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 the enrollment and the allocation visits:
    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.
    Pancreatic/biliary tract disease (e.g., pancreatitis) or paralytic ileus.
    Intake of forbidden concomitant medication/use of forbidden therapies (see synopsis
    ection Concomitant medications/therapies).
    Female participant is breastfeeding a child.
    The following will be checked at the allocation to treatment visit:
    Has received a drug or used a medical device not approved for human use within 30 days
    prior to visit.
    Based on data from the local laboratory, one or more of:
    Total serum bilirubin greater than 2.0 mg/dL.
    Serum albumin less than 2.8 g/dL.
    Aspartate transaminase or alanine transaminase greater than 5 times upper limit
    of normal.
    Based on data from the local laboratory, creatinine clearance less than 30 mL/min per
    73 m2 (calculated according to a formula that is appropriate for the respective age
    group).
    If the participant suffers from non-cancer related pain: participation in any
    interventional clinical trial within 30 days prior to visit.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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