Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX® Modified Release Tablets Administered to Patients Undergoing Colonoscopy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cosmo Technologies Ltd
- Enrollment
- 114
- Primary Endpoint
- Evaluation of Mucosal Staining Efficacy
Study Overview
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):
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
None. Open label
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
150 mg Methylene Blue-MMX tablets
take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg
Intervention: Methylene Blue MMX 25 mg modified release tablets (Drug)
200 mg Methylene Blue-MMX tablets
take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg
Intervention: Methylene Blue MMX 25 mg modified release tablets (Drug)
Outcomes
Primary Outcomes
Evaluation of Mucosal Staining Efficacy
Time Frame: One day- mucosal staining efficacy is assessed during the colonoscopy procedure
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 1. - traces (poor traces in colon mucosa) 2. - detectable (at least the 25% of colon mucosa is stained) 3. - acceptable (at least the 50% of colon mucosa is stained) 4. - good (at least the 75% of colon mucosa is stained) 5. - 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.
Secondary Outcomes
- Safety and Tolerability of Methylene Blue MMX as Determined by AEs(Until study completion (until 2 days after dose))
- Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate(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)(until study completion (until 2 days after dose))
- Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.(until study completion (until 2 days after dose))
- Bowel Cleansing Quality-Boston Bowel Preparation Score(One day- bowel cleansing quality is assessed during the colonoscopy procedure)
- Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)(until study completion (until 2 days after dose))