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
Conditions
Interventions
Product Name: 10% phenylephrine gel
Pharmaceutical Form: Gel
INN or Proposed INN: PHENYLEPHRINE HYDROCHLORIDE
CAS Number: 61767
Concentration unit: % percent
Concentration type: equal
Concentration nu
Sponsors
S.L.A. Pharma (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: • A history of surgery to the anal sphincter complex • Active pouchitis (determined by clinical examination and macroscopic inflammation on endoscopy. Patients on maintenance antibiotics need not be excluded but their antibiotic dose should remain the same throughout the study) • Undergone pelvic radiotherapy at any time • Cardiac or cardiovascular disease, including ischaemic heart disease, history of stroke, cerebral arteriosclerosis, aneurysm, tachycardia or hypertension • Hyperthyroidism or diabetes mellitus • Crohn’s disease (indeterminate colitis is not an exclusion criterion) • The use of a- or ß-adrenoceptor agonists (other than inhaled ß-adrenoceptor agonists) or antagonists, other sympathomimetics or any cardiovascular drugs during the study (including eyedrops, nasal drops and OTC cold cures containing phenylephrine or pseudoephedrine) • The use of mono-amine oxidase inhibitors or tricyclic antidepressants in the 4 weeks prior to the first dose of study medication or during the study • Any mental or other impairment which, in the investigator’s opinion, would render them unlikely to be able to comply with the requirements of the study • Considered by their physician unlikely to be able to comply with the protocol • Participation in a clinical trial within the past three months • Known hypersensitivity to phenylephrine or excipients • History of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 ;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). | — |
Countries
United Kingdom
Outcome results
None listed