Low Back Pain Clinical Trial
Official title:
Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus Oxycodone/Naloxone PR in Non-opioid Pre-treated Subjects With Uncontrolled Severe Chronic Low Back Pain With a Neuropathic Pain Component.
This was a clinical effectiveness trial designed to compare the effectiveness, safety, and
tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone
prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with
a neuropathic pain component.
Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol
and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus
oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics
with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the
neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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