At a glance
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Open-Label Extension, Single-Arm, Flexible-Dosing, Phase 3 Trial With CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain
In Brief
A Phase 3 clinical trial evaluating Tapentadol (CG5503) Extended Release (ER) for Pain and 2 related conditions. Completed, enrolled 1,166 participants across 148 sites in 4 countries.
Detailed Summary
The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes.
Study Details
Timeline
Interventions
100, 150, 200, 250 mg oral tablet twice daily for 52 weeks