Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jervoise Andreyev

ORCID ID

Contact details

Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 (0)20 8643 8901

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Faecal incontinence

Intervention

Normacol versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Normacol

Primary outcome measures

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 trial start date

01/07/2003

Overall trial end date

30/05/2007

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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

http://www.dh.gov.uk/Home/fs/en

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes