Pain Clinical Trial
Official title:
An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of
tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back
pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. 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 outcome.
The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with
that of tapentadol hydrochloride prolonged release treatment during defined periods of
evaluation.
n/a
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