Colorectal CancerPhase 2NCT02295774
Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA
A Phase 2 study testing Methylene Blue MMX tablets in people with Colorectal Cancer, run by Cosmo Technologies Ltd at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Methylene Blue MMX tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Administration of Methylene Blue MMX Tablets on Double-stranded DNA Damage Assessed by GammaH2AX Analysis of Colon Biopsy Samples
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.
Read the detailed description
Primary Objective: To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets, (administered as 8 x 25 mg), prior to endoscopy, on double-stranded DNA breaks in colonic biopsy samples assessed by histone γH2AX analysis, compared to control biopsies collected during standard white light colonoscopy without the prior use of Methylene Blue MMX®.
Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX® tablets.. To evaluate the staining score for colonoscopy obtained with oral Methylene Blue MMX® tablets . Time to reach the caecum during colonoscopy and withdrawal time from caecum to exit.
- Conditions
- Colorectal Cancer
- Being tested
- standard white light colonoscopy-equivalent to placebo, Methylene Blue MMX tablets
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard white light colonoscopy-equivalent to placeboProcedure or surgery
standard white light colonoscopy
Methylene Blue MMX tabletsDrug
8x25mg methylene blue MMX tablets administered before a colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Biopsy samples collected during standard white light colonoscopy. Receives: Procedure: standard white light colonoscopy-equivalent to placebo |
| Group B | Active comparator | 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. Receives: Drug: Methylene Blue MMX tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.
Measured: 2 weeks
Secondary outcomes (1)
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.
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
- 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)
- overstained ( the 100% of the colon mucosa is over stained)
Measured: During the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Principal investigator, IRCCS Instituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295774
- Sponsor's protocol ID
- CB-17-01/08
- Other IDs
- 2013-000634-35
- Status last verified
- Apr 2018
- First submitted
- 12 Nov 2014
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Repici 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.
PubMed 29906809
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Administration of Methylene Blue MMX Tablets on Double-stranded DNA Damage Assessed by GammaH2AX Analysis of Colon Biopsy Samples
- ClinicalTrials.gov ID
- NCT02295774
- Acronym / sponsor ID
- CB-17-01/08
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 13 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective: To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets, (administered as 8 x 25 mg), prior to endoscopy, on double-stranded DNA breaks in colonic biopsy samples assessed by histone γH2AX analysis, compared to control biopsies collected during standard white light colonoscopy without the prior use of Methylene Blue MMX®.
Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX® tablets.. To evaluate the staining score for colonoscopy obtained with oral Methylene Blue MMX® tablets . Time to reach the caecum during colonoscopy and withdrawal time from caecum to exit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Procedure: standard white light colonoscopy-equivalent to placeboBiopsy samples collected during standard white light colonoscopy. |
| Group B | Active comparator | Drug: Methylene Blue MMX tabletsSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard white light colonoscopy-equivalent to placebostandard white light colonoscopy | Procedure or surgery | Group A |
| Methylene Blue MMX tablets8x25mg methylene blue MMX tablets administered before a colonoscopy | Drug | Group B |
Primary outcome
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
Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.
1 secondary outcome
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.
Time frame: During the colonoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29906809Repici 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Repici, MD principal investigator
IRCCS Instituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylene Blue MMX tablets in people with Colorectal Cancer, run by Cosmo Technologies Ltd at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.