A double-blind, randomised, placebo-controlled study to evaluate topical 10%phenylephrine gel applied peri-anally in the management of ileal pouch anal anastomosis (IPAA)-related faecal incontinence

INTERVENTION: Product Name: 10% phenylephrine gel Pharmaceutical Form: Gel INN or Proposed INN: PHENYLEPHRINE HYDROCHLORIDE CAS Number: 61767 Concentration unit: % percent Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Topical use (Noncurrent) CONDITION: Ileal pouch anal anastomosis (IPAA)‐related faecal incontinence ; MedDRA version: 14.1 Level: PT Classification code 10016092 Term: Faecal incontinence System Organ Class: 10017947 ‐ Gastrointestinal disorders PRIMARY OUTCOME: Main Objective: The primary objective is to determine the effect of 10% phenylephrine hydrochloride gel, applied three times a day, on the change from baseline to the end of study in the faecal incontinence score (St Mark’s) in subjects with IPAA‐related faecal incontinence, compared with placebo. Primary end point(s): The primary efficacy variable will be the change from baseline to the end of study in the faecal incontinence score (St Mark’s). Secondary Objective: The secondary objectives are to determine the effect of topical phenylephrine, compared with placebo, on:‐; ; • Number of daytime faecal incontinence episodes of liquid/mucus and solid stool; • Number of nights with nocturnal incontinence episodes of liquid/mucus and solid stool; • Number of incontinence episodes of gas; • Faecal incontinence quality of life scale; • Subject satisfaction with treatment; • Subject assessment of overall change from baseline; • Loperamide or other constipating agent usage; • Anal manometry measurements; • Safety and tolerability will be assessed by physical examination, biochemical and haematological markers and the incidence of adverse events; INCLUSION CRITERIA: A subject will be considered eligible for this study only if all of the following criteria apply: • Incontinence of solid or liquid stool/mucus following ileo‐anal pouch construction, at least once per week over the last month • At least six months must have elapsed since IPAA surgery or six months since closure of a loop ileostomy created during IPAA surgery, whichever is the later • Aged 18 years or over • If female, the subject must not be lactating and must be (a) post‐menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study • Written informed consent to participate has been provided NB: Seepage, leakage, soiling of faecal material is regarded as incontinence. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects