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Sökning: onr:"swepub:oai:DiVA.org:uu-302234" > Libertas :

  • 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 ...

  • 2016
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-302234
  • urn:nbn:se:uu:diva-302234urn
  • https://doi.org/10.1007/s00384-016-2585-7DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • gratis
  • gratis
  • 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

  • Faecal incontinence
  • Quality of life
  • Episode frequency
  • Alpha-1 receptor agonist
  • NRL001

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Graf, WilhelmUppsala universitet,Kolorektalkirurgi(Swepub:uu)wilhgraf (författare)
  • Emmanuel, A.Univ Coll Hosp, 235 Euston Rd, London, England. (författare)
  • Walker, D.Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England. (författare)
  • Shing, R. Ng KwetNorgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England. (författare)
  • Pediconi, C.Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England. (författare)
  • Pilot, J.Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England. (författare)
  • Wexner, S.Cleveland Clin Florida, Weston, FL USA. (författare)
  • Scholefield, J.Univ Nottingham Hosp, Div Surg, Nottingham NG7 2UH, England. (författare)
  • CHU Pontchaillou, Rennes, France.Kolorektalkirurgi (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:International Journal of Colorectal Disease31:6, s. 1205-12160179-19581432-1262

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