Faecal IncontinencePhase 3NCT00420797
A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
A Phase 3 study testing 10% Phenylephrine hydrochloride gel in people with Faecal Incontinence, run by S.L.A. Pharma AG at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- 10% Phenylephrine hydrochloride gel
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2007to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Faecal Incontinence
- Being tested
- 10% Phenylephrine hydrochloride gel
- 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
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Phenylephrine hydrochloride gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startFeb 2007
- Study completionNov 2007
Why it stopped: Terminated, new protocol to be developed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan Clark, MD FRCS, Principal investigator, St Mark's Hospital, The North West London Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420797
- Sponsor's protocol ID
- P/PFI/01
- Status last verified
- Nov 2007
- First submitted
- 9 Jan 2007
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00420797
- Acronym / sponsor ID
- P/PFI/01
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated, new protocol to be developed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Phenylephrine hydrochloride gel | Drug | – |
Primary outcome
The primary efficacy variable will be the change from baseline to the end of study in the faecal incontinence score (St Mark's)
15 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Clark, MD FRCS principal investigator
St Mark's Hospital, The North West London Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% Phenylephrine hydrochloride gel in people with Faecal Incontinence, run by S.L.A. Pharma AG at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy variable will be the change from baseline to the end of study in the faecal incontinence score (St Mark's). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.