A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of Tapentadol Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain.

Trial Profile

A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of Tapentadol Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2016

At a glance

  • Drugs Tapentadol (Primary) ; Oxycodone
  • Indications Back pain; Musculoskeletal pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 21 May 2011 Results from a pooled analysis (700020566, 700023303 and 700058693) of a subset of patients aged at least 75 years were presented at the 30th Annual Scientific Meeting of the American Pain Society.
    • 27 Sep 2010 Results reported in a PriCara media release.
    • 02 Sep 2010 Results from a pooled analysis (700020566, 700023303 and 700058693) were reported at the 13th World Congress on Pain.
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