Sökning: onr:"swepub:oai:DiVA.org:uu-302234" >
Libertas :
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Siproudhis, L.CHU Pontchaillou, Rennes, France.
(författare)
Libertas : a phase II placebo-controlled study of NRL001 in patients with faecal incontinence showed an unexpected and sustained placebo response
- Artikel/kapitelEngelska2016
Förlag, utgivningsår, omfång ...
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2016-04-13
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Springer Science and Business Media LLC,2016
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electronicrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-302234
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-302234URI
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https://doi.org/10.1007/s00384-016-2585-7DOI
Kompletterande språkuppgifter
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Språk:engelska
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Sammanfattning på:engelska
Ingår i deldatabas
Klassifikation
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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Faecal incontinence (FI) is distressing, significantly reduces quality of life (QoL) and has few pharmacological treatments. The alpha(1)-adrenoceptor agonist NRL001 (1R,2S-methoxamine hydrochloride) improves anal sphincter tone. NRL001 efficacy was evaluated by changes in Wexner scores at week 4 vs. baseline in NRL001-treated patients compared with placebo. Impact of NRL001 on QoL and safety were also assessed. Four hundred sixty-six patients received NRL001 (5, 7.5 or 10 mg) or placebo as suppository, once daily over 8 weeks. Wexner score, Vaizey score and QoL were analysed at baseline, week 4 and week 8. FI episodes and adverse events were recorded in diaries. At week 4, mean reductions in Wexner scores were -3.0, -2.6, -2.6 and -2.4 for NRL001 5, 7.5, 10 mg and placebo, respectively. All reduced further by week 8. As placebo responses also improved, there was no significant treatment effect at week 4 (p = 0.6867) or week 8 (p = 0.5005). FI episode frequency improved for all patients, but not significantly compared with placebo (week 4: p = 0.2619, week 8: p = 0.5278). All patients' QoL improved, but not significantly for all parameters (p > 0.05) except depression/self-perception at week 4 (p = 0.0102) and week 8 (p = 0.0069), compared with placebo. Most adverse events were mild and judged probably or possibly related to NRL001. All groups demonstrated improvement in efficacy and QoL compared with baseline. NRL001 was well-tolerated without serious safety concerns. Despite the improvement in all groups, there was no statistically significant treatment effect, underlining the importance of relating results to a placebo arm.
Ämnesord och genrebeteckningar
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Faecal incontinence
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Quality of life
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Episode frequency
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Alpha-1 receptor agonist
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NRL001
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Graf, WilhelmUppsala universitet,Kolorektalkirurgi(Swepub:uu)wilhgraf
(författare)
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Emmanuel, A.Univ Coll Hosp, 235 Euston Rd, London, England.
(författare)
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Walker, D.Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
(författare)
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Shing, R. Ng KwetNorgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
(författare)
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Pediconi, C.Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
(författare)
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Pilot, J.Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
(författare)
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Wexner, S.Cleveland Clin Florida, Weston, FL USA.
(författare)
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Scholefield, J.Univ Nottingham Hosp, Div Surg, Nottingham NG7 2UH, England.
(författare)
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CHU Pontchaillou, Rennes, France.Kolorektalkirurgi
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:International Journal of Colorectal Disease: Springer Science and Business Media LLC31:6, s. 1205-12160179-19581432-1262
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