| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN41155448 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | RANM09 |
| Public title | A Randomised, Double Blind, Placebo Controlled Study to Assess the Effects of Ranitidine on the Survival of Patients with Gastric Cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Stomach |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | GlaxoSmithKline |
| Sponsor name | Glaxo Wellcome (UK) |
| Sponsor details | Stockley Park West
Uxbridge, Middlesex
United Kingdom
UB11 1BT |
| Sponsor telephone | +44(0) 20 8990 9000 |
| Sponsor fax | +44(0) 20 8990 4321 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://uk.gsk.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN41155448 |
| Date last extracted from ISRCTN register | 17/04/2008 |
