| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN14545665 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | RANX05 |
| Public title | A Randomised Double-Blind Multicentre Placebo-Controlled Study to Investigate the Effect of Ranitidine on the Post-Operative Infection Rate and Survival Rate of Patients Undergoing Surgery for Colorectal Cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Colon, Rectum |
| 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, international |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 31/12/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| 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 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 | ISRCTN14545665 |
| Date last extracted from ISRCTN register | 17/04/2008 |
