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 |
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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 |
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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 |
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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. 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 |
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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 |