Trial · Interventional

CompletedPhase 2Results postedRegistry data

Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA

NCTNCT02295774Other idCB-17-01/08Other id2013-000634-35

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 10 participants (actual)
Sponsor: Cosmo Technologies Ltd · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Italy
Start: Feb 2013
Primary completion: Dec 2014
Completion: Dec 2014
First posted: 20 Nov 2014 (estimated)
Last update posted: 5 Nov 2018
Conditions: Colorectal Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015

Ph 2
Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA
NCT02295774
Feb 2013 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Single Centre, open label assignment phase II clinical study. To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma H2AX analysis, compared to control biopsies.

Interventions

standard white light colonoscopy-equivalent to placeboProcedure
Methylene Blue MMX tabletsDrug

Arms2

Placebo comparator
Group A
Biopsy samples collected during standard white light colonoscopy.
Active comparator
Group B
Subjects who have had samples collected during a Group A colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their previous group A colonoscopy for histone gamma H2AX activity.

Primary outcomes1

Outcomes the sponsor listed as primary.

Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy
Time frame · 2 weeks
Registry description
Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.

Secondary outcomes(1)

To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.
Time frame · During the colonoscopy
Registry description
Staining quality (SC) observed in each colonic region, in the FAS set (N=10); mean (±SD) is reported for SC. SC is ranked as follows: 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. overstained ( the 100% of the colon mucosa is over stained)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 2 weeks

Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy

Group	Value (subject biopsies that tested + for γH2AX)
MB MMX 200mg	0

Secondary and other outcome results(1)

Secondary outcomeMean· During the colonoscopy

To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.

Group	Value (Units on a 6 point scale)	Spread
MB MMX 200mg	2.9	1.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
MB MMX 200mgBiopsy samples collected during standard white light colonoscopy. No study drug was taken prior to initial Colonoscopy (White light only) Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy	0 / 13	0 / 13	8 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedRepici A, Ciscato C, Wallace M, Sharma P, Anderloni A, Carrara S, Di Leo M, Hassan C. Evaluation of genotoxicity related to oral methylene blue chromoendoscopy. Endoscopy. 2018 Oct;50(10):1027-1032. doi: 10.1055/a-0630-1004. Epub 2018 Jun 15. PMID 29906809

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Males or females, aged between 18 and 75. * Outpatients scheduled for screening or surveillance colonoscopy * Subjects must be identified as having the clinical requirement for second colonoscopy within 2weeks of the initial colonoscopy. * Women of childbearing potential must use at least one reliable method of contraception, be surgically sterilised or be abstinent. * For female subjects, a negative serum pregnancy test is required before Methylene Blue MMX® tablets are dispensed to the subject. * Post menopausal patients need to have a period of greater than 1year since last menstrual period. * Subjects must be able to comprehend the full nature and purpose of the study, including possible risks and side effects. * Subjects must be able to co-operate with the investigator and to comply with the requirements of the entire study. * Signed written informed consent prior to inclusion in the study. Exclusion Criteria: * No Pregnant or lactating women, or women undergoing fertility treatment. * No previous medical history of, or suspected hypersensitivity to the Methylene Blue and/or this formulations ingredients. * No previous medical history of, or suspected hypersensitivity to the PEG based bowel cleansing preparation and/or this formulations ingredients. * No previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease. * No ALT, AST, GGT, Bilirubin, Creatinine or Urea greater than 2.5 x the upper limit for normal, based on local laboratory testing. * No clinical alarm symptoms or history of anaemia (previously recorded haemoglobin of less than 10mg/dL) or frank blood in the stool within the last 30 days prior to enrolment. * No known deficiency of glucose-6-phosphate dehydrogenase. * No known deficiency of NADPH reductase. * No treatment within 5 weeks prior to randomisation with Fluoxetine (Prozac). * No concurrent treatment, or previous treatment within 2 weeks with any of the prohibited psychiatric medications that may interact with Methylene Blue as listed in the Prohibited Medications section; Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinepherine Reuptake Inhibitors (SNRI's), listed Tricyclic anti-depressants or Monoamine oxidase A inhibitors. * No concurrent treatment with anticoagulants, or antiaggregants, inducing an INR \> 1.5. * No current enrolment in any other clinical trial, or previous enrolment in a clinical trial within the last 30 days. * No other medical condition that in the investigators opinion would make the administration of the study drug or procedures hazardous to the subject. Exclusion Criteria: \-

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