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

ISRCTN ISRCTN17865479
DOI https://doi.org/10.1186/ISRCTN17865479
Secondary identifying numbers N0263115181
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
28/07/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
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

Mr R Kushwaha
Scientific

Department of Oncology
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom

Phone +44 (0)20 7636 8333
Email r.kushwaha@ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe use of misoprostol suppositories to reduce radiotherapy-induced anorectal dysfunction
Study objectivesWhat 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute radiation proctitis
InterventionRandomised controlled clinical trial:
1. Misoprostol suppositories
2. Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Misoprostol
Primary outcome measureA reduction in acute radiation proctitis symptoms.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/2002
Completion date01/10/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50
Key inclusion criteria50 patients from oncology
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/07/2002
Date of final enrolment01/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Middlesex Hospital
London
W1N 8AA
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

University College London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

28/07/2017: No publications found in PubMed, verifying study status with principal investigator.