Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RANX05
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Not Specified
Patient information sheet
Condition
Colon, Rectum
Intervention
1. 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 type
Drug
Phase
Not Specified
Drug names
Ranitidine
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Glaxo Wellcome (UK)
Sponsor details
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (UK)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
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
Basic results (scientific)
Publication list