Clinical trial NCT03287219: Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
Official title: Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX® Modified Release Tablets Administered to Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Staining in Preparation for Colonoscopy
Lead sponsor: Cosmo Pharmaceuticals NV
Sponsor class: INDUSTRY
Collaborators: name: Cross S.A.
First posted: 2017-09-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, staining efficacy exploratory study.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Sex: males and females;
2. Age:18 to 70 years;
3. Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
4. Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
5. Informed Consent: signed written informed consent prior to inclusion in the study.

Exclusion Criteria:

1. Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
2. Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
3. 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.
4. 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.

Primary outcomes:
measure: Evaluation of Mucosal Staining Efficacy
timeFrame: One day- mucosal staining efficacy is assessed during the colonoscopy procedure
Secondary outcomes:
measure: Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)
timeFrame: until study completion (until 2 days after dose)
measure: Safety and Tolerability of Methylene Blue MMX as Determined by AEs
timeFrame: Until study completion (until 2 days after dose)
measure: Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate
timeFrame: until study completion (until 2 days after dose)
measure: Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)
timeFrame: until study completion (until 2 days after dose)
measure: Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.
timeFrame: until study completion (until 2 days after dose)
measure: Bowel Cleansing Quality-Boston Bowel Preparation Score
timeFrame: One day- bowel cleansing quality is assessed during the colonoscopy procedure
Other outcomes:
Locations:
Study officials:
References: