Clinical trial

An Open-label Extension Study With Flexible Dosing of Extended-release (ER)…

NCT00487435 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed

Key facts

NCT number NCT00487435
Title An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Official title Open-Label Extension, Single-Arm, Flexible-Dosing, Phase 3 Trial With CG5503 Extended-Release (ER) in Patients With Moderate to Severe 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 Pain, Osteoarthritis, Low Back Pain
Intervention type Drug
Interventions Tapentadol (CG5503) Extended Release (ER)
Enrollment 1,166
Start date Jun 1, 2007
Primary completion Jun 1, 2009
Completion Jun 1, 2009
First posted Jun 18, 2007
Last update posted May 9, 2014
Countries Australia, Canada, New Zealand, 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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