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
NCT ID: NCT01112644
Last Updated: 2018-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
205 participants
INTERVENTIONAL
2010-04-30
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain
NCT01439100
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
NCT01197261
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
NCT00412100
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
NCT04759703
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
NCT01358526
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OXN PR
Different daily doses; intake every 12 hours
Oxycodone naloxone prolonged release tablets (OXN PR)
Different daily doses; intake every 12 hours
PLA
Different daily doses; intake every 12 hours
Oxycodone naloxone prolonged release tablets (OXN PR)
Different daily doses; intake every 12 hours
Placebo (PLA)
Different daily doses; intake every 12 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oxycodone naloxone prolonged release tablets (OXN PR)
Different daily doses; intake every 12 hours
Placebo (PLA)
Different daily doses; intake every 12 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mundipharma Research GmbH & Co KG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Paracelsus Elena Klinik
Kassel, , Germany
Barcelona, , Spain
Gothenburg, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Oertel WH, Hallstrom Y, Saletu-Zyhlarz GM, Hopp M, Bosse B, Trenkwalder C; RELOXYN Study Group. Sleep and Quality of Life Under Prolonged Release Oxycodone/Naloxone for Severe Restless Legs Syndrome: An Analysis of Secondary Efficacy Variables of a Double-Blind, Randomized, Placebo-Controlled Study with an Open-Label Extension. CNS Drugs. 2016 Aug;30(8):749-60. doi: 10.1007/s40263-016-0372-1.
Trenkwalder C, Benes H, Grote L, Garcia-Borreguero D, Hogl B, Hopp M, Bosse B, Oksche A, Reimer K, Winkelmann J, Allen RP, Kohnen R; RELOXYN Study Group. Prolonged release oxycodone-naloxone for treatment of severe restless legs syndrome after failure of previous treatment: a double-blind, randomised, placebo-controlled trial with an open-label extension. Lancet Neurol. 2013 Dec;12(12):1141-50. doi: 10.1016/S1474-4422(13)70239-4. Epub 2013 Oct 18.
Related Links
Access external resources that provide additional context or updates about the study.
Results available on website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-011107-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OXN3502
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.