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Libertas : a phase II placebo-controlled study of NRL001 in patients with faecal incontinence showed an unexpected and sustained placebo response
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- Siproudhis, L. (författare)
- CHU Pontchaillou, Rennes, France.
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- Graf, Wilhelm (författare)
- Uppsala universitet,Kolorektalkirurgi
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- Emmanuel, A. (författare)
- Univ Coll Hosp, 235 Euston Rd, London, England.
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- Walker, D. (författare)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
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- Shing, R. Ng Kwet (författare)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
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- Pediconi, C. (författare)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
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- Pilot, J. (författare)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
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- Wexner, S. (författare)
- Cleveland Clin Florida, Weston, FL USA.
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- Scholefield, J. (författare)
- Univ Nottingham Hosp, Div Surg, Nottingham NG7 2UH, England.
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CHU Pontchaillou, Rennes, France Kolorektalkirurgi (creator_code:org_t)
- 2016-04-13
- 2016
- Engelska.
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Ingår i: International Journal of Colorectal Disease. - : Springer Science and Business Media LLC. - 0179-1958 .- 1432-1262. ; 31:6, s. 1205-1216
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://link.springe...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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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.
Nyckelord
- Faecal incontinence
- Quality of life
- Episode frequency
- Alpha-1 receptor agonist
- NRL001
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