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The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy

NCT01694966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1249

Last updated 2017-11-06

Study results available
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Summary

Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.

Conditions

Interventions

DRUG

Methylene Blue MMX®

DRUG

Placebo

Sugar pill manufactured to mimic Methylene Blue MMX® tablet.

Sponsors & Collaborators

  • Cosmo Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Alessandro Repici, MD · Co-ordinating Investigator EU

  • Michael Wallace, MD · Co-ordinating Investigator US

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Italy
  • Lithuania
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01694966 on ClinicalTrials.gov