A Randomised Double-Blind Multicentre Placebo-Controlled Study to Investigate the Effect of Ranitidine on the Post-Operative Infection Rate and Survival Rate of Patients Undergoing Surgery for Colorectal Cancer

ISRCTN ISRCTN14545665
DOI https://doi.org/10.1186/ISRCTN14545665
Secondary identifying numbers RANX05
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
11/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedColon, Rectum
Intervention1. Group A: Intravenous ranitidine, 100 mg, administered twice daily for 5 days or until oral treatment is tolerated, followed by oral ranitidine, 150 mg twice daily until death or for a period of 5 years.
2. Group B: Intravenous placebo, 100 mg, administered twice daily for 5 days or until oral treatment is tolerated, followed by oral placebo, 150 mg twice daily until death or for a period of 5 years.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ranitidine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Aged >18 years
2. Diagnosis of colorectal cancer
3. This is the first operation for cancer and the life expectancy of the patient is at least 3 months at the time of surgery
4. No concurrent chronic modulating therapy with systemic steroids, antiviral agents or other known immunomodulating drugs
5. No systemic antimicrobial agents in the 48 h prior to entry into the study
6. Not currently or planning to undergo chemotherapy, radiotherapy or any other therapy for cancer
7. No medical contraindications to protocol treatments
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Glaxo Wellcome (UK)
Industry

Stockley Park West
Uxbridge, Middlesex
UB11 1BT
United Kingdom

Website http://uk.gsk.com
ROR logo "ROR" https://ror.org/01xsqw823

Funders

Funder type

Industry

GlaxoSmithKline (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom

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