FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2118957503> ?p ?o ?g. }

• W2118957503 endingPage "1150" @default.
• W2118957503 startingPage "1141" @default.
• W2118957503 abstract "Opioids are a potential new treatment for severe restless legs syndrome. We investigated the efficacy and safety of a fixed-dose combination of prolonged release oxycodone-naloxone for patients with severe restless legs syndrome inadequately controlled by previous, mainly dopaminergic, treatment.This multicentre study consisted of a 12-week randomised, double-blind, placebo-controlled trial and 40-week open-label extension phase done at 55 sites in Austria, Germany, Spain, and Sweden. Patients had symptoms for at least 6 months and an International RLS Study Group severity rating scale sum score of at least 15; patients with severe chronic obstructive pulmonary disease or a history of sleep apnoea syndrome were excluded. Patients were randomly assigned (1:1) to either study drug or matched placebo with a validated interactive response technology system in block sizes of four. Study drug was oxycodone 5·0 mg, naloxone 2·5 mg, twice per day, which was up-titrated according to investigator's opinion to a maximum of oxycodone 40 mg, naloxone 20 mg, twice per day; in the extension, all patients started on oxycodone 5·0 mg, naloxone 2·5 mg, twice per day, which was up-titrated to a maximum of oxycodone 40 mg, naloxone 20 mg, twice per day. The primary outcome was mean change in severity of symptoms according to the International RLS Study Group severity rating scale sum score at 12 weeks. This study is registered with ClinicalTrials.gov (number NCT01112644) and with EudraCT (number 2009-011107-23).We screened 495 patients, of whom 306 were randomly assigned and 276 included in the primary analysis (132 to prolonged release oxycodone-naloxone vs 144 to placebo). 197 patients participated in the open-label extension. Mean International RLS Study Group rating scale sum score at randomisation was 31·6 (SD 4·5); mean change after 12 weeks was -16·5 (SD 11·3) in the prolonged release oxycodone-naloxone group and -9·4 (SD 10·9) in the placebo group (mean difference between groups at 12 weeks 8·15, 95% CI 5·46-10·85; p<0·0001). After the extension phase, mean sum score was 9·7 (SD 7·8). Treatment-related adverse events occurred in 109 of 150 (73%) patients in the prolonged release oxycodone-naloxone group and 66 of 154 (43%) in the placebo group during the double-blind phase; during the extension phase, 112 of 197 (57%) had treatment-related adverse events. Five of 306 (2%) patients had serious treatment-related adverse events when taking prolonged release oxycodone-naloxone (vomiting with concurrent duodenal ulcer, constipation, subileus, ileus, acute flank pain).Prolonged release oxycodone-naloxone was efficacious for short-term treatment of patients with severe restless legs syndrome inadequately controlled with previous treatment and the safety profile was as expected. Our study also provides evidence of open-label long-term efficacy of this treatment. Opioids can be used to treat patients with severe restless legs syndrome who have had no benefit with first-line drugs.Mundipharma Research." @default.
• W2118957503 created "2016-06-24" @default.
• W2118957503 creator A5008880258 @default.
• W2118957503 creator A5009516582 @default.
• W2118957503 creator A5022630766 @default.
• W2118957503 creator A5024419816 @default.
• W2118957503 creator A5027679081 @default.
• W2118957503 creator A5038560717 @default.
• W2118957503 creator A5040158309 @default.
• W2118957503 creator A5042577463 @default.
• W2118957503 creator A5047168727 @default.
• W2118957503 creator A5052235691 @default.
• W2118957503 creator A5087382572 @default.
• W2118957503 creator A5088552578 @default.
• W2118957503 date "2013-12-01" @default.
• W2118957503 modified "2023-10-17" @default.
• W2118957503 title "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" @default.
• W2118957503 cites W135426180 @default.
• W2118957503 cites W1496983321 @default.
• W2118957503 cites W1963944906 @default.
• W2118957503 cites W1968185119 @default.
• W2118957503 cites W1969313589 @default.
• W2118957503 cites W1970760101 @default.
• W2118957503 cites W1971976069 @default.
• W2118957503 cites W1979844313 @default.
• W2118957503 cites W1983717490 @default.
• W2118957503 cites W1990373951 @default.
• W2118957503 cites W1991792619 @default.
• W2118957503 cites W1999746377 @default.
• W2118957503 cites W1999888203 @default.
• W2118957503 cites W2003216452 @default.
• W2118957503 cites W2008052775 @default.
• W2118957503 cites W2017886518 @default.
• W2118957503 cites W2018582283 @default.
• W2118957503 cites W2019168520 @default.
• W2118957503 cites W2021353061 @default.
• W2118957503 cites W2028081267 @default.
• W2118957503 cites W2029320046 @default.
• W2118957503 cites W2040895462 @default.
• W2118957503 cites W2041336745 @default.
• W2118957503 cites W2056051056 @default.
• W2118957503 cites W2057577193 @default.
• W2118957503 cites W2061708351 @default.
• W2118957503 cites W2070048521 @default.
• W2118957503 cites W2076742337 @default.
• W2118957503 cites W2082178490 @default.
• W2118957503 cites W2085792179 @default.
• W2118957503 cites W2087629200 @default.
• W2118957503 cites W2089867828 @default.
• W2118957503 cites W2091605545 @default.
• W2118957503 cites W2092579502 @default.
• W2118957503 cites W2094663096 @default.
• W2118957503 cites W2096237051 @default.
• W2118957503 cites W2105044875 @default.
• W2118957503 cites W2113429239 @default.
• W2118957503 cites W2116484098 @default.
• W2118957503 cites W2133368859 @default.
• W2118957503 cites W2138901664 @default.
• W2118957503 cites W2139927499 @default.
• W2118957503 cites W2141893227 @default.
• W2118957503 cites W2143221646 @default.
• W2118957503 cites W2165897422 @default.
• W2118957503 cites W2408799309 @default.
• W2118957503 cites W3194956376 @default.
• W2118957503 doi "https://doi.org/10.1016/s1474-4422(13)70239-4" @default.
• W2118957503 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/24140442" @default.
• W2118957503 hasPublicationYear "2013" @default.
• W2118957503 type Work @default.
• W2118957503 sameAs 2118957503 @default.
• W2118957503 citedByCount "176" @default.
• W2118957503 countsByYear W21189575032012 @default.
• W2118957503 countsByYear W21189575032013 @default.
• W2118957503 countsByYear W21189575032014 @default.
• W2118957503 countsByYear W21189575032015 @default.
• W2118957503 countsByYear W21189575032016 @default.
• W2118957503 countsByYear W21189575032017 @default.
• W2118957503 countsByYear W21189575032018 @default.
• W2118957503 countsByYear W21189575032019 @default.
• W2118957503 countsByYear W21189575032020 @default.
• W2118957503 countsByYear W21189575032021 @default.
• W2118957503 countsByYear W21189575032022 @default.
• W2118957503 countsByYear W21189575032023 @default.
• W2118957503 crossrefType "journal-article" @default.
• W2118957503 hasAuthorship W2118957503A5008880258 @default.
• W2118957503 hasAuthorship W2118957503A5009516582 @default.
• W2118957503 hasAuthorship W2118957503A5022630766 @default.
• W2118957503 hasAuthorship W2118957503A5024419816 @default.
• W2118957503 hasAuthorship W2118957503A5027679081 @default.
• W2118957503 hasAuthorship W2118957503A5038560717 @default.
• W2118957503 hasAuthorship W2118957503A5040158309 @default.
• W2118957503 hasAuthorship W2118957503A5042577463 @default.
• W2118957503 hasAuthorship W2118957503A5047168727 @default.
• W2118957503 hasAuthorship W2118957503A5052235691 @default.
• W2118957503 hasAuthorship W2118957503A5087382572 @default.
• W2118957503 hasAuthorship W2118957503A5088552578 @default.
• W2118957503 hasConcept C126322002 @default.
• W2118957503 hasConcept C142724271 @default.
• W2118957503 hasConcept C170493617 @default.

• next