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
| ISRCTN | ISRCTN14545665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14545665 |
| Secondary identifying numbers | RANX05 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 11/07/2014
- 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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| 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 | Colon, Rectum |
| Intervention | 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. |
| 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 | 01/01/2002 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| 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. 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
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 |
|---|---|
"ROR" |
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 | |
|---|---|
| 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 |
