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CompletedNCT03287219CRO-11-108Updated Jan 28, 2021Results posted

Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

A Phase 2 interventional study of Methylene Blue MMX 25 mg modified release tablets in Colon Staining in Preparation for Colonoscopy, sponsored by Cosmo Technologies Ltd. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Cosmo Technologies Ltd · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 years 3 months after the study started (first participant enrolled May 2011, registered Aug 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
114
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colon Staining in Preparation for Colonoscopy
03

In context

Lead sponsor

Cosmo Technologies Ltd is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. : either sterile subjects or subjects practising at least one reliable methods of contraception or in status for at least 1 year;
  5. : signed written informed consent prior to inclusion in the study.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
  2. Allergy: known or suspected 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugMethylene 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.

06

What researchers measure

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.

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

Secondary outcomes

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

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

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

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

    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.

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

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

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

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

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

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

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

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

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

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

  6. Bowel Cleansing Quality-Boston Bowel Preparation Score

    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)

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

07

Results

Posted Jan 28, 2021

Participant flow

Participant flow — Overall Study
Milestone150 mg Methylene Blue-MMX Tablets200 mg Methylene Blue-MMX Tablets
Started2490
Completed2488
Not completed02
Withdrew: Protocol violation02

Outcome measures

PrimaryEvaluation 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.

Time frame:
One day- mucosal staining efficacy is assessed during the colonoscopy procedure
Reported as:
Mean · scores on a scale
Evaluation of Mucosal Staining Efficacy
scores on a scaleA (Dose:150mg)B (Dose:150mg)C (Dose:150mg)D (Dose:200mg)E (Dose:200mg)F (Dose:200mg)G (Dose 200mg)H (Dose:200mg)I (Dose:200mg)J (Dose:200mg)
Evaluation of Mucosal Staining Efficacy6.8 ± 4.02.3 ± 2.48.1 ± 3.67.0 ± 5.09.8 ± 4.110.5 ± 4.110.5 ± 7.810.0 ± 3.211.4 ± 3.811.6 ± 3.5
SecondarySafety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)

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

Time frame:
until study completion (until 2 days after dose)
Reported as:
Mean · mmHg
Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)
mmHgPre Colonoscopy - 150mg DosePre Colonoscopy- 200mg DoseDuring Colonoscopy- 150mg DoseDuring Colonoscopy- 200mg DosePost Colonoscopy- 150mg DosePost Colonoscopy- 200mg Dose
Systolic Blood Pressure (mmHg)122.6 ± 14.6124.3 ± 17.7122.6 ± 14.6124.3 ± 17.7122.7 ± 14.5124.2 ± 17.7
Diastolic Blood Pressure(mmHg)74.7 ± 8.174.0 ± 11.974.9 ± 8.274.0 ± 11.975 ± 8.274.0 ± 11.9
SecondarySafety and Tolerability of Methylene Blue MMX as Determined by AEs

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.

Time frame:
Until study completion (until 2 days after dose)
Reported as:
Count of participants · Participants
Safety and Tolerability of Methylene Blue MMX as Determined by AEs
ParticipantsPre Colonoscopy - 150mg DosePre Colonoscopy- 200mg DoseDuring Colonoscopy- 150mg DoseDuring Colonoscopy- 200mg DosePost Colonoscopy- 150mg DosePost Colonoscopy- 200mg Dose
Safety and Tolerability of Methylene Blue MMX as Determined by AEs330000
SecondarySafety and Tolerability of Methylene Blue MMX as Determined by Heart Rate

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

Time frame:
until study completion (until 2 days after dose)
Reported as:
Mean · beats per minute (BPM)
Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate
beats per minute (BPM)Pre Colonoscopy - 150mg DosePre Colonoscopy- 200mg DoseDuring Colonoscopy - 150mg DoseDuring Colonoscopy- 200mg DosePost Colonoscopy- 150mg DosePost Colonoscopy- 200mg Dose
Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate73.9 ± 10.675.2 ± 15.174.3 ± 10.975.3 ± 15.174.2 ± 10.97.1 ± 15.1
SecondarySafety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)

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

Time frame:
until study completion (until 2 days after dose)
Reported as:
Mean · percentage of saturation
Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)
percentage of saturationPre Colonoscopy - 150mg DosePre Colonoscopy- 200mg DoseDuring Colonoscopy- 150mg DoseDuring Colonoscopy- 200mg DosePost Colonoscopy- 150mg DosePost Colonoscopy- 200mg Dose
Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)98.4 ± 1.898.7 ± 6.698.4 ± 1.898.8 ± 6.598.4 ± 1.898.8 ± 6.5
SecondarySafety and Tolerability of Methylene Blue MMX as Determined Body Weight.

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

Time frame:
until study completion (until 2 days after dose)
Reported as:
Mean · Kg
Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.
KgVisit 1-Screening 150mLVisit 1-Screening 200mLVisit 2-Final 150mLVisit 2-Final 200mL
Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.67.2 ± 13.071.3 ± 15.967.4 ± 13.071.2 ± 15.8
SecondaryBowel Cleansing Quality-Boston Bowel Preparation Score

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)

Time frame:
One day- bowel cleansing quality is assessed during the colonoscopy procedure
Reported as:
Mean · Colon cleansing score
Bowel Cleansing Quality-Boston Bowel Preparation Score
Colon cleansing score150 mg Methylene Blue-MMX Tablets200 mg Methylene Blue-MMX TabletsOverall
Bowel Cleansing Quality-Boston Bowel Preparation Score5.4 ± 1.75.4 ± 1.15.4 ± 1.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AEs Methylene Blue-MMX Tablets Equivalent to 150 mg—0/24 (0%)1/24 (4.2%)
AEs Methylene Blue-MMX Tablets Equivalent to 200 mg—0/88 (0%)2/88 (2.3%)
Most frequent other events
Most frequent other events
EventAEs Methylene Blue-MMX Tablets Equivalent to 150 mgAEs Methylene Blue-MMX Tablets Equivalent to 200 mg
vomitingGastrointestinal disorders1/242/88

Baseline characteristics

Age, Continuous
Age, Continuous(years)Methylene Blue MMX 150mgMethylene Blue MMX 200mgTotal
Mean50.4 ± 11.055.6 ± 11.254.5 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)Methylene Blue MMX 150mgMethylene Blue MMX 200mgTotal
Female113546
Male135366
Height
Height(Centimetres)Methylene Blue MMX 150mgMethylene Blue MMX 200mgTotal
Mean166.5 ± 8.4168.5 ± 8.7167.4 ± 8.7
Body Weight
Body Weight(Kg)Methylene Blue MMX 150mgMethylene Blue MMX 200mgTotal
Mean68 ± 13.370.6 ± 14.269 ± 14.0
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2011 to primary completion in Jan 2012, 8 months.

Results were first posted in Jan 2021, 9 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Sep 19, 2017
StartActual
May 2, 2011
Primary completionActual
Jan 16, 2012
CompletionActual
Jan 16, 2012
Results first posted
Jan 28, 2021
Last update
Jan 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03287219
Lead sponsor
Cosmo Technologies Ltd
Collaborators
Cross S.A.
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
May 2, 2011
Primary completion
Jan 16, 2012
Completion
Jan 16, 2012
Results posted
Jan 28, 2021
Last update
Jan 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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