Overview

A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence

Status:
Withdrawn
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the study is to test the hypothesis that topical application of phenylephrine improves faecal continence and quality of life in subjects with passive faecal incontinence after ileo-anal pouch construction.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
S.L.A. Pharma AG
Treatments:
Oxymetazoline
Phenylephrine
Criteria
Inclusion Criteria:

- 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
(sterilization of partner, abstinence, an intra-uterine device (IUD), double barrier
method or oral hormonal contraception).

- Written informed consent to participate has been provided

NB: Seepage, leakage, soiling of faecal material is regarded as incontinence.

Exclusion Criteria:

- 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 α- or β-adrenoceptor agonists (other than inhaled β-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