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 |
| Protocol serial number | N0013150230 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust (UK), Own account, NHS R&D Support Funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 10% metronidazole ointment |
| Primary outcome measure(s) |
Peri-anal Crohn's disease activity index. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
General, Vascular & Colorectal Surgery
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
