Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX (CRO-11-108)

January 8, 2021 updated by: Cosmo Technologies Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 150 mg Methylene Blue-MMX tablets
take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg
Drug: 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.
Active Comparator: 200 mg Methylene Blue-MMX tablets
take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One day- mucosal staining efficacy is assessed during the colonoscopy procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
until study completion (until 2 days after dose)
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.
Until study completion (until 2 days after dose)
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
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)
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)
until study completion (until 2 days after dose)
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.
until study completion (until 2 days after dose)
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

  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)
One day- bowel cleansing quality is assessed during the colonoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cosmo Technologies Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cross S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CB-17-01/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Staining in Preparation for Colonoscopy

Clinical Trials on Methylene Blue MMX 25 mg modified release tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings