Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/04/2015
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

Mr R Kushwaha

ORCID ID

Contact details

Department of Oncology
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
+44 (0)20 7636 8333
r.kushwaha@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263115181

Study information

Scientific title

The use of misoprostol suppositories to reduce radiotherapy-induced anorectal dysfunction

Acronym

Study hypothesis

What are the long-term structural and functional changes in the anorectum following pelvic radiotherapy for prostate cancer, can they be prevented by the use of misoprostol suppositories?

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

Acute radiation proctitis

Intervention

Randomised controlled clinical trial:
1. Misoprostol suppositories
2. Placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Misoprostol

Primary outcome measures

A reduction in acute radiation proctitis symptoms.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

50 patients from oncology

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2002

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Middlesex Hospital
London
W1N 8AA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University College London Hospitals NHS Trust (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