Clinical trial

A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended…

NCT00449176 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed

Key facts

NCT number NCT00449176
Title A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
Official title 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 CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain
Lead sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry
Collaborators Grünenthal GmbH Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Low Back Pain
Intervention type Drug
Interventions tapentadol (CG5503) ER, oxycodone CR, placebo
Enrollment 981
Start date Feb 1, 2007
Primary completion May 1, 2008
Completion May 1, 2008
First posted Mar 20, 2007
Last update posted Apr 30, 2012

At a glance

  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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