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11 February 2012 
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A randomised controlled trial to evaluate topical 10% metronidazole ointment for the treatment of perianal Crohn's disease
ISRCTN ISRCTN54256247
ClinicalTrials.gov identifier
Public title A randomised controlled trial to evaluate topical 10% metronidazole ointment for the treatment of perianal Crohn's disease
Scientific title
Acronym N/A
Serial number at source N0013150230
Study hypothesis Does topical metronidazole treat patients with peri-anal Crohn's disease?
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Crohn's disease
Participants - inclusion criteria 30 patients with peri-anal Crohn's disease will be recruited throughout the course of the trial.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/06/2004
Anticipated end date 01/12/2004
Status of trial Completed
Patient information material
Target number of participants 30
Interventions 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.
Primary outcome measure(s) Peri-anal Crohn's disease activity index.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Guy's and St. Thomas' NHS Foundation Trust (UK)
2. Own account
3. NHS R&D Support Funding (UK)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20632322
Contact name Mr  Emin  Carapeti
  Address General, Vascular & Colorectal Surgery
1st Floor, North Wing
St. Thomas' Hospital
Lambeth Palace Road
  City/town London
  Zip/Postcode SE1 7EH
  Country United Kingdom
  Tel +44 (0)20 7188 2569
  Email emin.carapeti@gstt.sthames.nhs.uk
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 14/11/2011
Date ISRCTN assigned 30/09/2005
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