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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:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT01112644
First received: April 23, 2010
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112644

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

No publications provided

Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01112644     History of Changes
Other Study ID Numbers: OXN3502, 2009-011107-23
Study First Received: April 23, 2010
Last Updated: August 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria : Federal Ministry for Labour, Health, and Social Affairs
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on May 23, 2013