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 - A study to Evaluate 10% Phenylephrine Gel in the Management of Faecal Incontinence

Phase 1

• Conditions: Ileal pouch anal anastomosis (IPAA)-related faecal incontinence; MedDRA version: 14.1Level: PTClassification code 10016092Term: Faecal incontinenceSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2006-002739-25-GB
• Lead Sponsor: S.L.A. Pharma (UK) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-14
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified