Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

NCT03287219 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CB-17-01/03
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Staining in Preparation for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 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.

  One day- mucosal staining efficacy is assessed during the colonoscopy procedure

Secondary Outcomes (6)

• Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)

  until study completion (until 2 days after dose)

• 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)

Study Arms (2)

150 mg Methylene Blue-MMX tablets

ACTIVE COMPARATOR

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

Drug: Methylene Blue MMX 25 mg modified release tablets

200 mg Methylene Blue-MMX tablets

ACTIVE COMPARATOR

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

Drug: Methylene Blue MMX 25 mg modified release tablets

Interventions

Methylene Blue MMX 25 mg modified release tablets DRUG

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

150 mg Methylene Blue-MMX tablets; 200 mg Methylene Blue-MMX tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead
• Cross S.A.: collaborator

Results Point of Contact

• Title: R&D Manager
• Organization: Cosmo Technologies Ltd

rjones@cosmopharma.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None. Open label
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, staining efficacy exploratory study.

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: September 19, 2017
• Study Start: May 2, 2011
• Primary Completion: January 16, 2012
• Study Completion: January 16, 2012
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share