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

ISRCTN ISRCTN41155448
DOI https://doi.org/10.1186/ISRCTN41155448
Secondary identifying numbers RANM09
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
13/11/2012
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)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedGastric Cancer
Intervention1. 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 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 date01/01/2001
Completion date31/12/2005

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. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2001
Date of final enrolment31/12/2005

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