Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Staining in Preparation for Colonoscopy

Intervention / Treatment
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* Drug: Methylene Blue MMX 25 mg modified release tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: males and females; Age:18 to 70 years; Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check; Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year; Informed Consent: signed written informed consent prior to inclusion in the study. Exclusion Criteria: Pregnancy: pregnant or lactating women or at a risk of becoming pregnant; Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general; Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, inflammatory bowel diseases in active phase, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other relevant disease that might interfere with the aim of the study. Comprehension: inability to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator and to comply with the requirements of the entire study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label, staining efficacy exploratory study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150 mg Methylene Blue-MMX tablets<br>take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg | Drug: Methylene Blue MMX 25 mg modified release tablets<br>* Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.<br>|
| Active Comparator: 200 mg Methylene Blue-MMX tablets<br>take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg | Drug: Methylene Blue MMX 25 mg modified release tablets<br>* Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Mucosal Staining Efficacy | Mucosal staining efficacy of Methylene Blue MMX tablets after total oral doses of 150 or 200 mg. Methylene blue staining efficacy was assessed by scoring the observed percentage of staining as reported below for each colon region (AC, TC, DC, RES) 0 - no staining - traces (poor traces in colon mucosa) - detectable (at least the 25% of colon mucosa is stained) - acceptable (at least the 50% of colon mucosa is stained) - good (at least the 75% of colon mucosa is stained) - over stained ( the 100% of the colon mucosa is over stained) After scoring (SC) separately each colonic segment, the total staining score (TSC) was also calculated and the number of regions with an SC>2 (NSA) was determined. For each patient, the best effective TSC was set at 16, when SC=4 was detected in all 4 regions. SC=5 detected in any region and TSC>16, both denoting an overstaining of the mucosa, were defined as suboptimal results in colon staining. | One day- mucosal staining efficacy is assessed during the colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure) | safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (blood pressure) | until study completion (until 2 days after dose) | 
| Safety and Tolerability of Methylene Blue MMX as Determined by AEs | Safety and tolerability of Methylene Blue MMX® tablets after administration of total oral doses of 150 or 200 mg.AEs were assessed throughout the study. | Until study completion (until 2 days after dose) | 
| Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate | incidence of treatment emergent by measurement of vital signs (heart rate) to determine Safety and Tolerability of Methylene Blue MMX | until study completion (until 2 days after dose) | 
| Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood) | safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood) | until study completion (until 2 days after dose) | 
| Safety and Tolerability of Methylene Blue MMX as Determined Body Weight. | safety and tolerability of Methylene Blue MMX in relation to incidence of treatment emergent by body weight. | until study completion (until 2 days after dose) | 
| Bowel Cleansing Quality-Boston Bowel Preparation Score | Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS). Colon was divided into 4 target regions: ascending colon (AC), transverse colon (TC), descending colon (DC) and rectosigmoid (RES). Methylene blue staining efficacy was assessed scoring the observed staining percentage as reported below for each colon region: 0 - no staining - traces (poor traces in colon mucosa) - detectable (at least the 25% of colon mucosa is stained) - acceptable (at least the 50% of colon mucosa is stained) - good (at least the 75% of colon mucosa is stained) - over stained ( the 100% of the colon mucosa is over stained) | One day- bowel cleansing quality is assessed during the colonoscopy procedure |