Conditions: Colon Staining in Preparation for Colonoscopy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg arm 2: take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg

Interventions: intervention 1: Methylene Blue MMX 25 mg modified release tablets
Intervention descriptions: intervention 1: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.

Protocol document: