NCT02295774

Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA

Effect of Oral Administration of Methylene Blue MMX Tablets on Double-stranded DNA Damage Assessed by GammaH2AX Analysis of Colon Biopsy Samples

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cosmo Technologies Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	standard white light colonoscopy-equivalent to placebo	standard white light colonoscopy
DRUG	Methylene Blue MMX tablets	8x25mg methylene blue MMX tablets administered before a colonoscopy

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-11-20
• Last updated: 2018-11-05
• Results posted: 2016-01-13

Locations

1 site across 1 country: Italy