Clinical trial

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

NCT00364533 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Terminated

Key facts

NCT number NCT00364533
Title A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
Official title A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
Lead sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry
Collaborators Grünenthal GmbH Industry
Status Terminated
Phase Phase 3
Study type Interventional
Conditions Arthroplasty
Intervention type Drug
Interventions Tapentadol IR (CG5503), Placebo, Oxycodone HCL IR
Enrollment 367
Start date Oct 1, 2006
Primary completion Dec 1, 2007
Completion Dec 1, 2007
First posted Aug 15, 2006
Last update posted Apr 21, 2014
Countries Belgium, Canada, Finland, New Zealand, Spain, Sweden, United Kingdom, 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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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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