A Randomised, Double Blind, Placebo Controlled Study to Assess the Effects of Ranitidine on the Survival of Patients with Gastric Cancer
ISRCTN | ISRCTN41155448 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Ranitidine |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2001 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Glaxo Wellcome (UK)
Industry
Industry
Stockley Park West
Uxbridge, Middlesex
UB11 1BT
United Kingdom
Website | http://uk.gsk.com |
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https://ror.org/01xsqw823 |
Funders
Funder type
Industry
GlaxoSmithKline (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |