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

Mundipharma

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Idiopathic RLS With Daytime Symptoms

Treatments: Other: Placebo (PLA); Drug: Oxycodone naloxone prolonged release tablets (OXN PR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112644

OXN3502

2009-011107-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 2 patient groups, including a placebo group

OXN PR

Experimental group

Description:

Different daily doses; intake every 12 hours

Treatment:

Drug: Oxycodone naloxone prolonged release tablets (OXN PR)

PLA

Placebo Comparator group

Description:

Different daily doses; intake every 12 hours

Treatment:

Drug: Oxycodone naloxone prolonged release tablets (OXN PR)

Other: Placebo (PLA)