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

NCT00420797 | Withdrawn Phase 3

• 1 other identifier: P/PFI/01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Faecal Incontinence

Keywords

Faecal seepage; ileal pouch anal anastomosis (IPAA); quality of life; faecal incontinence; ileo-anal pouch construction; phenylephrine hydrochloride gel; IPAA-related faecal incontinence; placebo

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable will be the change from baseline to the end of study in the faecal incontinence score (St Mark's)

Secondary Outcomes (15)

• Efficacy:

• 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

Interventions

10% Phenylephrine hydrochloride gel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (1)

St Mark's Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Susan Clark, MD FRCS

  St Mark's Hospital, The North West London Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: February 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 19, 2015

Record last verified: 2007-11

Locations

GB (1)