NCT03287219

Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX® Modified Release Tablets Administered to Patients Undergoing Colonoscopy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Cosmo Technologies Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objectives: 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. Primary end-point(s): To evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg. Secondary end-point(s): Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS) after intake of 150 or 200 mg of Methylene Blue MMX® tablets during the intake of the bowel cleansing preparation. To collect data about safety and tolerability of Methylene Blue MMX® tablets after administration of single oral doses of 150 or 200 mg. Methodology: Open label, staining efficacy exploratory study.

Conditions

• Colon Staining in Preparation for Colonoscopy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-02
• Primary completion: 2012-01-16
• Completion: 2012-01-16
• First posted: 2017-09-19
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Regulatory

• FDA-regulated drug study