Back to resultsA Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
Primary Purpose
Faecal Incontinence
Status
Withdrawn
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
10% Phenylephrine hydrochloride gel
Sponsored by
About this trial
This is an interventional treatment trial for Faecal Incontinence focused on measuring Faecal seepage, ileal pouch anal anastomosis (IPAA), quality of life, faecal incontinence, ileo-anal pouch construction, phenylephrine hydrochloride gel, IPAA-related faecal incontinence, placebo
Eligibility 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
Sites / Locations
- St Mark's Hospital
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420797
Brief Title
A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated, new protocol to be developed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
S.L.A. Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
10% Phenylephrine hydrochloride gel
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy:
Title
Number of daytime faecal incontinence episodes of liquid/mucus and solid stool
Title
Number of nights with nocturnal incontinence episodes of liquid/mucus and solid stool
Title
Number of incontinence episodes of gas
Title
Faecal incontinence quality of life scale
Title
Subject satisfaction with treatment
Title
Subject assessment of overall change from baseline
Title
Loperamide or other constipating agent usage
Title
Anal manometry measurements
Title
Safety:
Title
AEs
Title
Blood pressure
Title
Pulse rate
Title
Changes in other physical examination findings
Title
Changes in biochemical or haematological markers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Clark, MD FRCS
Organizational Affiliation
St Mark's Hospital, The North West London Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mark's Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
We'll reach out to this number within 24 hrs