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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112644
First Posted: April 28, 2010
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
  Purpose

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.


Condition Intervention Phase
Moderate to Severe Idiopathic RLS With Daytime Symptoms Drug: Oxycodone naloxone prolonged release tablets (OXN PR) Other: Placebo (PLA) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Mundipharma Research GmbH & Co KG:

Primary Outcome Measures:
  • Changes in the IRLS score between the two treatment arms will be compared [ Time Frame: 12 weeks and a 6 month extension ]

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

    IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period.



Enrollment: 205
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OXN PR
Different daily doses; intake every 12 hours
Drug: Oxycodone naloxone prolonged release tablets (OXN PR)
Different daily doses; intake every 12 hours
Placebo Comparator: PLA
Different daily doses; intake every 12 hours
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

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112644


Locations
Germany
Paracelsus Elena Klinik
Kassel, Germany
Spain
Barcelona, Spain
Sweden
Goteborg, Sweden
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01112644     History of Changes
Other Study ID Numbers: OXN3502
2009-011107-23 ( EudraCT Number )
First Submitted: April 23, 2010
First Posted: April 28, 2010
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Restless Legs Syndrome
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists