Low Back Pain Clinical Trial
Official title:
Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus a Combination of Tapentadol PR and Pregabalin in Subjects With Severe Chronic Low Back Pain With a Neuropathic Pain Component
The main objective of the study is to evaluate the effectiveness, safety, and tolerability of
increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination
of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring
additional analgesia after titration to tapentadol PR 300 mg per day.
This is a clinical effectiveness trial designed to establish a link between anticipated
clinical outcomes and the clinical practice by means of selected measures of clinical and
subject reported outcomes. Since, severe low back pain with a neuropathic component, the
targeted study population, is frequently treated with a combination therapy (monotherapy is
often not effective enough) it is of interest to determine if tapentadol alone (combining 2
mechanisms of action in a single molecule) could be as effective as a combination of
tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus
combination are of interest.
Participants with a diagnosis of chronic low back pain (defined as pain lasting for at least
3 month) and requiring a strong analgesic (World Health Organization [WHO] Step III) as
judged by the investigator and having a positive or unclear score using the painDETECT
diagnostic screening questionnaire will enter the open-label titration tapentadol prolonged
release (PR) period. In total participants will have 11 planned scheduled visits scheduled
over 105 days. At the Enrollment Visit [Day -14 (3 to 14 days prior to the Baseline Visit)]
the inclusion and exclusion criteria will be checked to evaluate the participant's
eligibility for the trial. Participants on previous analgesics will start a washout period
three days up to 2 weeks.The duration of the washout period will depend on previous opioid
analgesics and co-analgesics and their respective doses, down-tapering steps. Participants
who do not need a washout of previous analgesic treatment (e.g. WHO Step I analgesics), a
baseline visit can be scheduled as soon as clinical laboratory monitoring results are
available.
At the Baseline Visit (Day 1) participants will start the 3 week open-label titration period
tapentadol prolonged release (PR) at doses of 2 x 50 mg per day and will be titrated upwards
in steps of 100 mg (2 x 50 mg) on a weekly basis.
Participants who do not qualify for randomization may continue the trial in the open-label
continuation arm if they have already reached a satisfactory level of pain relief.
Participants qualifying for randomization in the comparative period (Day 22 to 77) will be
allocated to 1 of 2 treatment arms and will continue treatment.
Either they continue on tapentadol prolonged release (PR) with increasing doses of tapentadol
PR
- After the randomization visit, participants will titrate up to a total daily dose of 400
mg.
- 1 week after the randomization visit, will titrate up to a total daily dose of 500 mg.
Participants in this treatment arm will receive a final dose of 500 mg tapentadol PR per
day.
Or start on a combination of tapentadol PR 300 mg per day with pregabalin
- After the randomization visit, participants will continue their previous regimen of
tapentadol PR 2 x 150 mg per day plus pregabalin 2 x 75 mg (total daily dose of 150 mg
pregabalin).
- 1 week after the randomization visit, participants will continue their previous regimen
(end of titration period) of tapentadol PR 2 x 150 mg per day plus pregabalin 2 x 150 mg
(total daily dose of 300 mg pregabalin). Participants in this treatment arm will receive
a final dose of 300 mg tapentadol PR and 300 mg pregabalin.
Participants in the Comparative Period can be assigned to the open-label pick-up arm and will
be treated with a stable dose of tapentadol PR 300 mg per day or 400 mg per day if they
experience treatment emergent adverse events (at least possibly related to investigational
medicinal product).The open-label pick-up period theoretically starts on Day 29, i.e. one
week after the Randomization Visit.
The Final Evaluation (Day 77) is planned to take place 8 weeks after randomization.
After the Final Evaluation a Follow-up Period (blinded tapering down/out of IMP in Week 12
and Follow-up Visit (up to Day 91) will take place. Tapering down/out of medication will be
performed according to the Summary of Product Characteristics.
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