Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.
During the first 2 weeks of the study (Part 1), participants were given either tapentadol or morphine prolonged-release (PR) tablets. Assignment was done randomly (like tossing a coin). The participant and the caregiver knew which medication the child was taking. The primary endpoint was based on data collected in Part 1 of this study. If eligible and willing, participants from Part 1 could enter a 12 month follow-up period (Part 2). In Part 2 of this study, participants were either treated with tapentadol PR tablets or entered observations arms where they were not treated at all or with standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
BE001
Leuven, Belgium
BG005
Pleven, Bulgaria
BG004
Number of Participants Classified as Responder (Part 1)
The proportion of participants classified as responders was assessed and compared between the treatment groups. A participant was defined as responder if both of the following criteria were met: * Completion of the 14-day Treatment Period (Part 1). * One of the following calculated from the scheduled pain assessments ("pain right now") documented during the last 3 days of the Treatment Period: * Average pain less than 50 on a visual analog scale (VAS, range 0 \[no pain\] to 100 \[pain as bad as it could be\]) for participants aged 12 years to less than 18 years; or less than 5 on the Faces Pain Scale-revised (FPS-R, range 0 \[no pain\] and 10 \[very much pain\]) for participants aged 6 years to less than 12 years. * Average reduction from baseline of pain greater than or equal to 20 on a VAS for participants aged 12 years to less than 18 years; or greater than or equal to 2 on the FPS-R for participants aged 6 years to less than 12 years.
Time frame: From Day 1 up to Day 14 (End of Part 1)
Extent of Constipation (Part 1)
Constipation was assessed using the modified constipation assessment scale (mCAS). This is an 8-item questionnaire where the observer has scored constipation on a nominal scale (no Problem \[score 0\], some problem \[score 1\] or severe Problem \[score 2\]). The response to an item could also be scored as "unable to assess". The Total Score can vary from 0-16; the higher the Total Score the higher the extent of constipation. A positive change from Day 1 to Day 14 indicates a worsening, a negative change an improvement.
Time frame: From Day 1 to Day 14 (End of Part 1)
Tolerability Over the Complete Trial Period
Tolerability was assessed by the number of participants with exactly 1 to more than 5 treatment emergent adverse events (TEAE) by treatment group during the different trial periods, on a participant level. In addition, tolerability was assessed by the number of participants with TEAEs which were considered by the investigator to be at least possibly related to the treatment the participant received.
Time frame: Part 1: Day 1 (Start of Part 1) to Day 14; Part 2: Day 15 to Day 379 (End of Part 2)
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Plovdiv, Bulgaria
BG001
Sofia, Bulgaria
BG006
Sofia, Bulgaria
CL004
Santiago, Chile
CL001
Valparaíso, Chile
FR008
Amiens, France
FR004
Brest, France
FR002
Lille, France
...and 13 more locations