Clinical trial

A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503)…

NCT00361504 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed

Key facts

NCT number NCT00361504
Title A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
Official title A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic 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 Osteoarthritis, Hip, Knee, Lower Back Pain, Pain
Intervention type Drug
Interventions Oxycodone CR, Tapentadol (CG5503) ER
Enrollment 1,123
Start date Nov 1, 2006
Primary completion Jul 1, 2008
Completion Jul 1, 2008
First posted Aug 8, 2006
Last update posted Apr 29, 2014
Countries Canada, United States

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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