Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0258127574
Study information
Scientific title
Acronym
Study hypothesis
To determine the effectiveness of normacol for treating faecal incontinence.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration
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
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|