Chronic 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 Uncontrolled Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.
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 either WHO Step I or Step II analgesics or no regular analgesics.
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 (either WHO Step I
or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride
prolonged release (PR) treatment during defined periods of evaluation.
n/a
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