Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

NCT ID: NCT03287219

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-02
• Study Completion Date: 2012-01-16

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.

Conditions

Colon Staining in Preparation for Colonoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

150 mg Methylene Blue-MMX tablets

take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg

Group Type: ACTIVE_COMPARATOR

Methylene Blue MMX 25 mg modified release tablets

Intervention Type: DRUG

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

200 mg Methylene Blue-MMX tablets

take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg

Group Type: ACTIVE_COMPARATOR

Methylene Blue MMX 25 mg modified release tablets

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cross S.A.

INDUSTRY

Sponsor Role: collaborator

Cosmo Technologies Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CB-17-01/03

Identifier Type: -

Identifier Source: org_study_id