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
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 |
|---|---|
| emin.carapeti@gstt.sthames.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 10% metronidazole ointment |
| Primary outcome measure | Peri-anal Crohn's disease activity index. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2004 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 |
| Key inclusion criteria | 30 patients with peri-anal Crohn's disease will be recruited throughout the course of the trial. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
General, Vascular & Colorectal Surgery
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
