Conditions: Colorectal Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Biopsy samples collected during standard white light colonoscopy. arm 2: Subjects who have had samples collected during a Group A colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their previous group A colonoscopy for histone gamma H2AX activity.

Interventions: intervention 1: standard white light colonoscopy-equivalent to placebo intervention 2: Methylene Blue MMX tablets
Intervention descriptions: intervention 1: standard white light colonoscopy intervention 2: 8x25mg methylene blue MMX tablets administered before a colonoscopy

Protocol document: