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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 Crohn's Disease Activity
The purpose of this study is to compare changes in Perianal Crohn's Disease following use of locally applied 10% metronidazole ointment and a placebo.
Anorectal Crohn's 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 Crohn's disease is reported in 3 to 5% of Crohn's patients. In Crohn's 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 Crohn's disease. In spite of the previously reported painless nature of anorectal Crohn's disease, it is the author's experience that the condition can be inordinately painful due to deeply eroding fissures, oedematous skin tags, and painful induration of the perianal region.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Washington University School of Medicine
St Louis, Missouri, United States
Derby City General Hospital
Derby, Derbyshire, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, United Kingdom
Monklands Hospital
Airdrie, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
University Hospital of Warwick and Coventry
Coventry, United Kingdom
St Marks Hospital
Harrow, United Kingdom
St Thomas Hospital
London, United Kingdom
Start Date
May 1, 2005
Primary Completion Date
February 1, 2008
Completion Date
February 1, 2008
Last Updated
December 13, 2012
74
ACTUAL participants
10% Metronidazole Ointment
DRUG
Lead Sponsor
S.L.A. Pharma AG
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06918808