Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
11/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RANX05

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Ranitidine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Glaxo Wellcome (UK)

Sponsor details

Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

Sponsor type

Industry

Website

http://uk.gsk.com

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (UK)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes