A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence - Full Text View

Sponsor:	S.L.A. Pharma AG
Information provided by:	S.L.A. Pharma AG
ClinicalTrials.gov Identifier:	NCT00420797

Purpose

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.

Condition	Intervention	Phase
Faecal Incontinence	Drug: 10% Phenylephrine hydrochloride gel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Topical 10% Phenylephrine Gel in the Management of Ileal Pouch Anal Anastomosis (IPAA)-Related Faecal Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Urinary Incontinence

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by S.L.A. Pharma AG:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
Subject satisfaction with treatment
Subject assessment of overall change from baseline
Loperamide or other constipating agent usage
Anal manometry measurements
Safety:
AEs
Blood pressure
Pulse rate
Changes in other physical examination findings
Changes in biochemical or haematological markers

Enrollment:	0
Study Start Date:	February 2007
Study Completion Date:	November 2007

Detailed Description:

Faecal seepage and even frank incontinence at night can be a problem for approximately 30% of patients who have undergone ileal pouch anal anastomosis (IPAA). Nocturnal seepage may be a problem in patients who do not have gross incontinence, or who may even have no incontinence during the day. Although baseline continence during the day is maintained by involuntary control of the internal anal sphincter, this can be supplemented by voluntary contraction of the external sphincter. While sleeping, this supplementary external sphincter effect is lost and internal anal sphincter tone is reduced, leading to seepage. This is obviously distressing and leads some patients to wear a pad to reduce the soiling that may occur.

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 (8 weeks)in the faecal incontinence score (St Mark's) with passive faecal incontinence after ileo-anal pouch construction, compared with placebo.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420797

Locations

United Kingdom
St Mark's Hospital
Harrow, Middlesex, United Kingdom, HA1 3UJ

Sponsors and Collaborators

S.L.A. Pharma AG

Investigators

Principal Investigator:

Susan Clark, MD FRCS

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00420797 History of Changes
Other Study ID Numbers:	P/PFI/01
Study First Received:	January 9, 2007
Last Updated:	November 28, 2007
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by S.L.A. Pharma AG:

Faecal seepage
ileal pouch anal anastomosis (IPAA)
quality of life
faecal incontinence

ileo-anal pouch construction
phenylephrine hydrochloride gel
IPAA-related faecal incontinence
placebo

Additional relevant MeSH terms:

Fecal Incontinence
Urinary Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Phenylephrine
Oxymetazoline
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012