Colorectal CancerPhase 3NCT01694966
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
A Phase 3 study testing Methylene Blue MMX® in people with Colorectal Cancer, run by Cosmo Technologies Ltd at 19 sites in 8 countries.
Trial summary
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Methylene Blue MMX®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,249 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Sep 2013to Oct 2016
- Phase
- Phase 3
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, aged between 50 and 75.
- Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
- Able to comprehend the full nature and purpose of the study, including possible risks and side effects.
- 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
- Patients at high risk of colorectal cancer e.g. ulcerative colitis
- Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients.
- Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
- Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
United States7 sites
Dr Marcia Canto
Baltimore, Maryland, 21287
Dr Michael Wallace
Jacksonville, Florida, 32224
Dr Prateek Sharma
Kansas City, Kansas, 66103
Dr David Gatof
Lafayette, Colorado, 80026
Dr Michelle Young
Phoenix, Arizona, 85012
Dr David Bruining
Rochester, Minnesota, 55905
Dr Francesco Ramirez
Scottsdale, Arizona, 85259
Italy3 sites
Dr Renato Cannizzaro
Aviano
Dr Cesare Hassan
Rome
Dr Alessandro Repici
Rozzano
Netherlands3 sites
Dr Evelien Dekker
Amsterdam
Dr Manoon Spander
Rotterdam
Dr Peter Siersema
Utrecht
United Kingdom2 sites
Dr James East
Oxford
Dr Matthew Rutter
Stockton-on-Tees
About this study
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
- Conditions
- Colorectal Cancer
- Being tested
- Methylene Blue MMX®, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene Blue MMX®Drug
Also called Investigational Product: Methylene Blue MMX® modified release tablets, Active Ingredient: Methylene Blue
PlaceboDrug
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue MMX® 200mg | Active comparator | Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule Receives: Drug: Methylene Blue MMX® |
| Methylene Blue MMX® 100mg | Active comparator | Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule Receives: Drug: Methylene Blue MMX®; Drug: Placebo |
| Placebo | Placebo comparator | Oral dose, 8 Placebo tablets over a 4hr schedule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.
Adenoma Detection Rate
Measured: +7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2013
- Primary completionOct 2016
- Study completionOct 2016
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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,249 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, Co-ordinating Investigator EUMichael Wallace, MD, Principal investigator, Co-ordinating Investigator US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694966
- Sponsor's protocol ID
- CB-17-01/06
- Other IDs
- 2012-003983-32
- Status last verified
- Oct 2017
- First submitted
- 25 Sep 2012
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Repici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10.
PubMed 30742834
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT01694966
- Acronym / sponsor ID
- CB-17-01/06
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,249 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue MMX® 200mg | Active comparator | Drug: Methylene Blue MMX®Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule |
| Methylene Blue MMX® 100mg | Active comparator | Drug: Methylene Blue MMX®, Drug: PlaceboOral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule |
| Placebo | Placebo comparator | Drug: PlaceboOral dose, 8 Placebo tablets over a 4hr schedule |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females, aged between 50 and 75.
- Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
- Able to comprehend the full nature and purpose of the study, including possible risks and side effects.
- 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.
Key exclusion criteria (4 listed)
- Patients at high risk of colorectal cancer e.g. ulcerative colitis
- Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients.
- Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
- Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
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 |
|---|---|---|
| Methylene Blue MMX®Also: Investigational Product: Methylene Blue MMX® modified release tablets, Active Ingredient: Methylene Blue | Drug | Methylene Blue MMX® 100mg, Methylene Blue MMX® 200mg |
| PlaceboSugar pill manufactured to mimic Methylene Blue MMX® tablet. | Drug | Methylene Blue MMX® 100mg, Placebo |
Primary outcome
To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.
Time frame: +7 days
Adenoma Detection Rate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30742834Repici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10.
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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
Co-ordinating Investigator EU
Michael Wallace, MD principal investigator
Co-ordinating Investigator US
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylene Blue MMX® in people with Colorectal Cancer, run by Cosmo Technologies Ltd at 19 sites in 8 countries.
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 5 inclusion and 4 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Italy, Netherlands, United Kingdom, Belgium and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Nov 2017). 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?
To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma. (time frame: +7 days). 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 NCT01694966, 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 6 Nov 2017.