Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509639
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2007-07-30
Brief Title:
Evaluation of Topical 10 Metronidazole Ointment for the Treatment of Active Perianal Crohns Disease
Sponsor:
SLA Pharma AG
Organization:
SLA Pharma AG
Study Overview
Official Title:
Phase III Study to Evaluate the Effect of 10 Metronidazole Ointment Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohns Disease Activity
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare changes in Perianal Crohns Disease following use of locally applied 10 metronidazole ointment and a placebo
Detailed Description:
Anorectal Crohns disease is one of the most problematic and debilitating conditions encountered in colorectal practise The condition is usually chronic debilitating and frequently refractory to current medications Failure to respond to medical therapy may ultimately result in proctocolectomy and ileostomy even in the absence of more proximal colonic disease Isolated anorectal Crohns disease is reported in 3 to 5 of Crohns patients In Crohns patients as a whole anorectal involvement is reported in up to one third to one half of patients in addition to either colonic or enteric Crohns disease In spite of the previously reported painless nature of anorectal Crohns disease it is the authors experience that the condition can be inordinately painful due to deeply eroding fissures oedematous skin tags and painful induration of the perianal region
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