A Randomised, Double Blind, Placebo Controlled Study to Assess the Effects of Ranitidine on the Survival of Patients with Gastric 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

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Gastric Cancer
Intervention	1. Arm A: Ranitidine 50 mg in 20 ml 0.9% saline or 5% dextrose to be given intravenously three times daily until oral treatment is tolerated. This will be followed by ranitidine 150 mg tablet twice daily until death or for a period of 5 years. 2. Arm B: Placebo 50 mg in 20 ml 0.9% saline or 5% dextrose to be given intravenously three times daily until oral treatment is tolerated. This will be followed by placebo 150 mg tablet twice daily until death or for a period of 5 years.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ranitidine
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex
Key inclusion criteria	1. Aged <18 years 2. Gastric cancer proven by histology and endoscopy or barium meal 3. Patients selected for laparotomy must commence intravenous treatment with study drug at the time of induction of anaesthesia 4. Adequate renal function 5. No previous resection for gastric cancer 6. No other prior or concurrent malignancy 7. No treatment with systemic steroids, hormones or other know immunomodulating drugs within the last 7 days prior to the start of the study period 8. No medical contraindications to study treatments
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2005

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes