Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420797
Status:
WITHDRAWN
Last Update Posted:
2015-05-19
First Post:
2007-01-09
Brief Title:
A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
Sponsor:
SLA Pharma AG
Organization:
SLA Pharma AG
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated new protocol to be developed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 weeksin the faecal incontinence score St Marks with passive faecal incontinence after ileo-anal pouch construction compared with placebo
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 weeksin the faecal incontinence score St Marks with passive faecal incontinence after ileo-anal pouch construction compared with placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None