Efficacy of Methylene Blue for screening/surveillance colonoscopy
Research type
Research Study
Full title
The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.
IRAS ID
140733
Contact name
James East
Contact email
Sponsor organisation
Cosmo Technologies Ltd
Eudract number
2012-003983-32
ISRCTN Number
n/a
Research summary
This is a randomised study that involves the use of placebo and doses of 200mg or 100mg Methylene Blue. Randomisation is a process where the group to which you are assigned is selected by chance. There are three groups: Group One will receive 200mg of Methylene Blue, Group Two will receive placebo and Group Three will receive a lower dose of 100mg of Methylene Blue. The randomisation scheme is 2:2:1 that means you have the same chance to be in the treatment arm or in the placebo arm and less chance of being in a low dose arm. Neither the patient nor the doctor will know the treatment (a double blind design) the pateint is receiving. The decision as to which treatment the patient receives will be random, like flipping a coin.
Early data from clinical studies with Methylene Blue MMX® have shown that patients who have a colonoscopy could benefit from Methylene Blue MMX® treatment. The dye may improve the doctors view of the patient’s colon during the colonoscopy and may help to show up areas of their colon which should be biopsied (removal of small tissue samples) for further laboratory tests.
It is hoped that the methylene blue tablets will increase the number of polyps the doctor is able to find during the patient’s colonoscopy. Finding and removing polyps during colonoscopy is thought to be a good way of preventing colorectal cancer.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0534
Date of REC Opinion
11 Nov 2013
REC opinion
Further Information Favourable Opinion