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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Research GmbH & Co KG
• Treatments: Naloxone; Oxycodone

Criteria

Inclusion Criteria:

• Moderate to severe idiopathic RLS with daytime symptoms

Exclusion Criteria:

• Females who are pregnant or lactating.

• Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

• Subjects with evidence of impaired liver/kidney function upon entry into the study