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Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

NCT03287219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-01-28

Study results available
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Summary

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Conditions

  • Colon Staining in Preparation for Colonoscopy

Interventions

DRUG

Methylene Blue MMX 25 mg modified release tablets

Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.

Sponsors & Collaborators

  • Cross S.A.

    collaborator INDUSTRY

  • Cosmo Technologies Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-02
Primary Completion
2012-01-16
Completion
2012-01-16
FDA Drug
Yes

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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 NCT03287219 on ClinicalTrials.gov