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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

2014-08-27 03:14:06 | BioPortfolio

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.

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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Moderate to Severe Idiopathic RLS With Daytime Symptoms

Intervention

Oxycodone naloxone prolonged release tablets (OXN PR), Placebo (PLA)

Location

Paracelsus Elena Klinik
Kassel
Germany

Status

Recruiting

Source

Mundipharma Research GmbH & Co KG

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:06-0400

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