Clinical trial

A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the…

NCT00478023 · Grünenthal GmbH, Industry · Completed

Key facts

NCT number NCT00478023
Title A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
Official title A Randomized, Double-blind, Parallel-arm, Placebo- and Comparator- Controlled Trial of the Efficacy and Safety of Multiple Doses of Immediate-release (IR) CG5503 for Postoperative Pain Following Abdominal Hysterectomy
Lead sponsor Grünenthal GmbH, Industry
Collaborators Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Hysterectomy, Postoperative
Intervention type Drug
Interventions Morphine, CG5503 IR, Placebo
Enrollment 854
Start date May 1, 2007
Primary completion Feb 1, 2008
Completion Apr 1, 2008
First posted May 24, 2007
Last update posted Oct 28, 2019
Countries Hungary, Latvia, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Ukraine

At a glance

  • 10–99 Study sites
  • 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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