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
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