NCT01112644

Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms

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 OXN PR Compared to Subjects Taking Placebo (PLA).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Moderate to Severe Idiopathic RLS With Daytime Symptoms

Interventions

Type	Name	Description
DRUG	Oxycodone naloxone prolonged release tablets (OXN PR)	Different daily doses; intake every 12 hours
OTHER	Placebo (PLA)	Different daily doses; intake every 12 hours

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-04-28
• Last updated: 2018-10-23

Locations

3 sites across 3 countries: Germany, Spain, Sweden