Contact information
Type
Scientific
Primary contact
Mr Emin Carapeti
ORCID ID
Contact details
General
Vascular & Colorectal Surgery
1st Floor
North Wing
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 2569
emin.carapeti@gstt.sthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013150230
Study information
Scientific title
Acronym
Study hypothesis
Does topical metronidazole treat patients with peri-anal Crohn's disease?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Crohn's disease
Intervention
This is a randomised, double blind, placebo-controlled, parallel group clinical trial comparing placebo and 10% metronidazole ointment for the treatment of perianal Crohn's disease.
Intervention type
Drug
Phase
Not Applicable
Drug names
10% metronidazole ointment
Primary outcome measures
Peri-anal Crohn's disease activity index.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2004
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
30 patients with peri-anal Crohn's disease will be recruited throughout the course of the trial.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2004
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
General, Vascular & Colorectal Surgery
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20632322
Publication citations
-
Results
Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T, Stone CD, Carapeti E, Vaizey CJ, , Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease., Br J Surg, 2010, 97, 9, 1340-1347, doi: 10.1002/bjs.7121.