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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

April 23, 2010
August 9, 2012
April 2010
June 2011   (final data collection date for primary outcome measure)
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.

Changes in the IRLS score between the two treatment arms will be compared [ Time Frame: 12 weeks ] [ 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.

Complete list of historical versions of study NCT01112644 on ClinicalTrials.gov Archive Site
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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
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).

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Moderate to Severe Idiopathic RLS With Daytime Symptoms
  • 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
  • Experimental: OXN PR
    Different daily doses; intake every 12 hours
    Intervention: Drug: Oxycodone naloxone prolonged release tablets (OXN PR)
  • Placebo Comparator: PLA
    Different daily doses; intake every 12 hours
    Interventions:
    • Drug: Oxycodone naloxone prolonged release tablets (OXN PR)
    • Other: Placebo (PLA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain,   Sweden
 
NCT01112644
OXN3502, 2009-011107-23
No
Mundipharma Research GmbH & Co KG
Mundipharma Research GmbH & Co KG
Not Provided
Not Provided
Mundipharma Research GmbH & Co KG
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP