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

NCT02295774 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Cosmo Technologies Ltd
Phase	Phase 2
Status	COMPLETED
Enrolment	10
Start date	2013-02
Completion	2014-12

Conditions

• Colorectal Cancer

Interventions

• standard white light colonoscopy-equivalent to placebo
• Methylene Blue MMX tablets

Primary outcomes

• Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy — 2 weeks
  Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.

Countries

Italy