Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes