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Clinical Trial Summary

The primary objective for the 12-week Titration-/Maintenance Period is:

To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.


Clinical Trial Description

A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01112644
Study type Interventional
Source Mundipharma Research GmbH & Co KG
Contact
Status Completed
Phase Phase 3
Start date April 2010
Completion date June 2011