Randomised controlled trial of Normacol for faecal incontinence after pelvic radiotherapy
| ISRCTN | ISRCTN15517721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15517721 |
| Protocol serial number | N0258127574 |
| Sponsor | Department of Health |
| Funders | The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine the effectiveness of normacol for treating faecal incontinence. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Faecal incontinence |
| Intervention | Normacol versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Normacol |
| Primary outcome measure(s) |
Would be the first study of any kind to report benefit for any treatment in this group of patients with this condition. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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. |
| Key exclusion criteria | 1. Patients unlikely to survive 1 year 2. Patients unable to give informed consent |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 30/05/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
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 |
