Colon Staining in Preparation for ColonoscopyPhase 2CRO-11-108NCT03287219
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
A Phase 2 study testing Methylene Blue MMX 25 mg modified release tablets in people with Colon Staining in Preparation for Colonoscopy, run by Cosmo Technologies Ltd.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Staining in Preparation for Colonoscopy
- What is being tested?
- Methylene Blue MMX 25 mg modified release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2011to 16 Jan 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: males and females;
- Age:18 to 70 years;
- Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
- Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
- Informed Consent: signed written informed consent prior to inclusion in the study.
Who cannot join
- Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
- Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
- 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.
- 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.
About this study
Official title: 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.
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.
- Being tested
- Methylene Blue MMX 25 mg modified release tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene Blue MMX 25 mg modified release tabletsDrug
Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
| Study group | Role | What they receive |
|---|---|---|
| 150 mg Methylene Blue-MMX tablets | Active comparator | take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg Receives: Drug: Methylene Blue MMX 25 mg modified release tablets |
| 200 mg Methylene Blue-MMX tablets | Active comparator | take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg Receives: Drug: Methylene Blue MMX 25 mg modified release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- - 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)
- - 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.
Measured: One day- mucosal staining efficacy is assessed during the colonoscopy procedure
Secondary outcomes (6)
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)
Measured: until study completion (until 2 days after dose)
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.
Measured: Until study completion (until 2 days after dose)
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
Measured: 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)
safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood)
Measured: until study completion (until 2 days after dose)
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.
Measured: until study completion (until 2 days after dose)
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
- - 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)
- - over stained ( the 100% of the colon mucosa is over stained)
Measured: One day- bowel cleansing quality is assessed during the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start2 May 2011
- Primary completion16 Jan 2012
- Study completion16 Jan 2012
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.
- Other trials for Colon Staining in Preparation for ColonoscopyStudies 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
- Parallel groups
- Model description
- Open label, staining efficacy exploratory study.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287219
- Sponsor's protocol ID
- CB-17-01/03
- Acronym
- CRO-11-108
- Status last verified
- Jan 2021
- First submitted
- 22 Aug 2017
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX® Modified Release Tablets Administered to Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT03287219
- Acronym / sponsor ID
- CRO-11-108 / CB-17-01/03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Study start
- 2 May 2011 (actual)
- Primary completion
- 16 Jan 2012 (actual)
- Study completion
- 16 Jan 2012 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Posted 28 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, staining efficacy exploratory study.
| Arm | Type | Receives |
|---|---|---|
| 150 mg Methylene Blue-MMX tablets | Active comparator | Drug: Methylene Blue MMX 25 mg modified release tabletstake 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg |
| 200 mg Methylene Blue-MMX tablets | Active comparator | Drug: Methylene Blue MMX 25 mg modified release tabletstake 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex: males and females;
- Age:18 to 70 years;
- Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
- Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
- Informed Consent: signed written informed consent prior to inclusion in the study.
Key exclusion criteria (4 listed)
- Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
- Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
- 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.
- 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.
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 25 mg modified release tabletsMethylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation. | Drug | 150 mg Methylene Blue-MMX tablets, 200 mg Methylene Blue-MMX tablets |
Primary outcome
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.
6 secondary outcomes
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 as Determined by AEs
Time frame: 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)
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 as Determined Body Weight.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylene Blue MMX 25 mg modified release tablets in people with Colon Staining in Preparation for Colonoscopy, run by Cosmo Technologies Ltd.
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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 28 Jan 2021). 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?
Evaluation of Mucosal Staining Efficacy (time frame: One day- mucosal staining efficacy is assessed during the colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.