Randomised controlled trial of Normacol for faecal incontinence after pelvic radiotherapy
| ISRCTN | ISRCTN15517721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15517721 |
| Secondary identifying numbers | N0258127574 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Jervoise Andreyev
Scientific
Scientific
Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8643 8901 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | To determine the effectiveness of normacol for treating faecal incontinence. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Faecal incontinence |
| Intervention | Normacol versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Normacol |
| Primary outcome measure | Would be the first study of any kind to report benefit for any treatment in this group of patients with this condition. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2003 |
| Overall study end date | 30/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | Any patient with episodes of active or passive faecal incontinence one or more per month at least 3 months after the completion of pelvic radiotherapy who did not have pre-existing incontinence. |
| Participant exclusion criteria | 1. Patients unlikely to survive 1 year 2. Patients unable to give informed consent |
| Recruitment start date | 01/07/2003 |
| Recruitment end date | 30/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
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
The Royal Marsden NHS Foundation Trust (UK)
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 |
