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OpenTrials
Completed

NCT Number: NCT03287219

Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

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.

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Key information

Conditions

Colon Staining in Preparation for Colonoscopy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    • - 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.

Secondary outcomes

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

    Time frame: until study completion (until 2 days after dose)

    safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (blood pressure)

  2. Safety and Tolerability of Methylene Blue MMX as Determined by AEs

    Time frame: Until study completion (until 2 days after dose)

    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.

  3. Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate

    Time frame: until study completion (until 2 days after dose)

    incidence of treatment emergent by measurement of vital signs (heart rate) to determine Safety and Tolerability of Methylene Blue MMX

  4. Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)

    Time frame: until study completion (until 2 days after dose)

    safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood)

  5. Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.

    Time frame: until study completion (until 2 days after dose)

    safety and tolerability of Methylene Blue MMX in relation to incidence of treatment emergent by body weight.

  6. Bowel Cleansing Quality-Boston Bowel Preparation Score

    Time frame: One day- bowel cleansing quality is assessed during the colonoscopy procedure

    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)

Sponsors and collaborators

Lead sponsor

Cosmo Technologies Ltd

Industry

Collaborators

  • Cross S.A.

Registry information

Official study title

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

Acronym: CRO-11-108

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 19, 2017
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.