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

NCT02295774 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-05

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Cosmo Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Alessandro Repici, MD · IRCCS Instituto Clinico Humanitas

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02295774 on ClinicalTrials.gov