# 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

> **NCT01112644** · PHASE3 · COMPLETED · sponsor: **Mundipharma Research GmbH & Co KG** · enrollment: 205 (actual)

## Conditions studied

- Moderate to Severe Idiopathic RLS With Daytime Symptoms

## Interventions

- **DRUG:** Oxycodone naloxone prolonged release tablets (OXN PR)
- **OTHER:** Placebo (PLA)

## Key facts

- **NCT ID:** NCT01112644
- **Lead sponsor:** Mundipharma Research GmbH & Co KG
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-04
- **Primary completion:** 2011-06
- **Final completion:** 2011-06
- **Target enrollment:** 205 (ACTUAL)
- **Last updated:** 2018-10-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01112644

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT01112644. Licensed CC0.

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