A randomised controlled trial to evaluate topical 10% metronidazole ointment for the treatment of perianal Crohn's disease

ISRCTN ISRCTN54256247
DOI https://doi.org/10.1186/ISRCTN54256247
Secondary identifying numbers N0013150230
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
14/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Emin Carapeti
Scientific

General, Vascular & Colorectal Surgery
1st Floor, North Wing
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone +44 (0)20 7188 2569
Email emin.carapeti@gstt.sthames.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesDoes topical metronidazole treat patients with peri-anal Crohn's disease?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCrohn's disease
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)10% metronidazole ointment
Primary outcome measurePeri-anal Crohn's disease activity index.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2004
Completion date01/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteria30 patients with peri-anal Crohn's disease will be recruited throughout the course of the trial.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/2004
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

General, Vascular & Colorectal Surgery
London
SE1 7EH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust (UK)

No information available

Own account

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2010 Yes No