Search: WFRF:(Pediconi C.)
> English >
Libertas
Libertas a phase II placebo-controlled study of NRL001 in patients with faecal incontinence showed an unexpected and sustained placebo response
-
Siproudhis, L. (author)
-
Graf, Wilhelm (author)
-
Emmanuel, A. (author)
-
show more...
-
Walker, D. (author)
-
Shing, R. Ng Kwet (author)
-
Pediconi, C. (author)
-
Pilot, J. (author)
-
Wexner, S. (author)
-
Scholefield, J. (author)
-
show less...
-
(publisher)
- 2016
- 2016
- English.
-
In: International Journal of Colorectal Disease. - 0179-1958. ; 31:6, 1205-1216
Abstract
Subject headings
Close
- 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.
Subject headings
- Medical and Health Sciences (hsv)
- Medicin och hälsovetenskap (hsv)
Keyword
- Faecal incontinence
- Quality of life
- Episode frequency
- Alpha-1 receptor agonist
- NRL001
Find in a library
To the university's database