Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
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.