Colorectal Cancer Clinical Trial
Official title:
Effect of Oral Administration of Methylene Blue MMX Tablets on Double-stranded DNA Damage Assessed by GammaH2AX Analysis of Colon Biopsy Samples
Single Centre, open label assignment phase II clinical study.
To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to
endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma
H2AX analysis, compared to control biopsies.
Primary Objective: To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets,
(administered as 8 x 25 mg), prior to endoscopy, on double-stranded DNA breaks in colonic
biopsy samples assessed by histone γH2AX analysis, compared to control biopsies collected
during standard white light colonoscopy without the prior use of Methylene Blue MMX®.
Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX®
tablets.. To evaluate the staining score for colonoscopy obtained with oral Methylene Blue
MMX® tablets . Time to reach the caecum during colonoscopy and withdrawal time from caecum to
exit.
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