Prolonged-release oxycodone-naloxone for treatment of severe pain in patients with Parkinson's disease (PANDA): a double-blind, randomised, placebo-controlled trial
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
26494524
DOI
10.1016/s1474-4422(15)00243-4
PII: S1474-4422(15)00243-4
Knihovny.cz E-zdroje
- MeSH
- bolest komplikace farmakoterapie MeSH
- dvojitá slepá metoda MeSH
- fixní kombinace léků MeSH
- léky s prodlouženým účinkem MeSH
- lidé středního věku MeSH
- lidé MeSH
- naloxon aplikace a dávkování terapeutické užití MeSH
- opioidní analgetika aplikace a dávkování terapeutické užití MeSH
- oxykodon aplikace a dávkování terapeutické užití MeSH
- Parkinsonova nemoc komplikace MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- fixní kombinace léků MeSH
- léky s prodlouženým účinkem MeSH
- naloxon MeSH
- opioidní analgetika MeSH
- oxykodon MeSH
BACKGROUND: Pain is a common non-motor symptom of Parkinson's disease. We investigated the analgesic efficacy of prolonged-release oxycodone-naloxone (OXN PR) in patients with Parkinson's disease and chronic, severe pain. METHODS: We did this phase 2 study in 47 secondary care centres in the Czech Republic, Germany, Hungary, Poland, Romania, Spain, and the UK. We enrolled patients with Hoehn and Yahr Stage II-IV Parkinson's disease, at least one type of severe pain, and an average 24-h pain score of at least 6 (assessed on an 11-point rating scale from 0=no pain to 10=pain as bad as you can imagine). Participants were randomly assigned (1:1) with a validated automated system (block size four) to either oral OXN PR or placebo for 16 weeks (starting dose oxycodone 5 mg, naloxone 2·5 mg, twice daily). Patients and investigators were masked to treatment assignment. The primary endpoint was average 24-h pain score at 16 weeks in the full analysis population. This study is registered with EudraCT (2011-002901-31) and ClinicalTrials.gov (NCT01439100). FINDINGS: We enrolled 202 patients; 93 were assigned to OXN PR and 109 to placebo; the full analysis population consisted of 88 patients versus 106 patients. Least squares mean average 24-h pain score at 16 weeks in the full analysis population was 5·0 (95% CI 4·5 to 5·5) in the OXN PR group versus 5·6 (5·1 to 6·0) in the placebo group (difference -0·6, 95% CI -1·3 to 0·0; p=0·058). Similar proportions of patients in each group had adverse events (60/92 [65%] vs 76/109 [70%]), treatment-related adverse events (52/92 [57%] vs 62/109 [57%]), and serious adverse events (5/92 [5%] vs 7/109 [6%]). Treatment-related nausea was more common in the OXN PR group than in the placebo group (16/92 [17%] vs 10/109 [9%]), as was treatment-related constipation (16/92 [17%] vs 6/109 [6%]). INTERPRETATION: The primary endpoint, based on the full analysis population at week 16, was not significant. Nonetheless, the results of this study highlight the potential efficacy of OXN PR for patients with Parkinson's disease-related pain and might warrant further research on OXN PR in this setting. FUNDING: Mundipharma Research.
Clinical Investigation Centre 1436 INSERM Toulouse France; University Hospital Toulouse France
Department of Neurology Jagiellonian University Krakow Poland
Department of Neurology Vaszary Kolos Hospital Esztergom Hungary
Mundipharma Research Cambridge UK
Mundipharma Research Limburg an der Lahn Germany
National Centre of Epidemiology Carlos 3 Institute of Health Madrid Spain
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