Ulcerative ColitisPhase 2NCT01520324

Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy

A Phase 2 study testing oral delivery mucosal stain in people with Ulcerative Colitis, run by Cosmo Technologies Ltd at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ulcerative Colitis
What is being tested?: oral delivery mucosal stain
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteItaly
Study dates: Jan 2012to Jul 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

endoscopically verified UC signed written informed consent

Who cannot join

Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Centre for Research & Care of Intestinal Diseases
Rozzano, 20089

Other trials in Italy

About this study

Official title: Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.

Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.

Conditions: Ulcerative Colitis
Being tested: oral delivery mucosal stain
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral delivery mucosal stainDevice
200mg methylene blue MMX tablet taken prior to colonoscopy

Study groups in NCT01520324
Study group	Role	What they receive
Patients with UC undergoing colonoscopy	Experimental	Not described Receives: Device: oral delivery mucosal stain

What is being measured

The primary outcome is the main question the study is designed to answer.

Detected Intraepithelial Neoplasia
Rate of intraepithelial neoplasiae detection in the whole colon.
Measured: During colonscopy (usually <15 min) and subsequent histological analysis
Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Measured: During colonscopy (usually <15 min) and subsequent histological analysis
Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Measured: During colonscopy (usually <15 min) and subsequent histological analysis
Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Measured: During colonscopy (usually <15 min) and subsequent histological analysis
Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Measured: During colonscopy (usually <15 min) and subsequent histological analysis

Secondary outcomes (3)

The Extent and Severity of the Inflamed Mucosa
The inflammation conditions of the mucosa were evaluated during the colonoscopy and, afterwards, in the bioptic specimens.
Rachmilewitz EI and Saverymuttu scores were used to assess inflammation. Rachmilewitz's scoring system for endoscopic index (EI) measures granulation scattering reflected light, vascular pattern, vulnerability of mucose and mucosal damage on a scoring scale of 0 to 4 from normal to damaged.
Saverymuttu's scoring system for enteric specimens assesses disease activity in the bowel by rating histological changes in enterocytes, crypts, lamina propria mononuclear cells and lamina propria neutrophils.
The average score for histological changes in individual biopsy specimens was summed and converted into a grade from 1 to 4, increasing in severity.
Measured: During colonscopy (usually <15 min) and subsequent histological analysis
The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation.
The mucosal staining efficacy of Methylene Blue MMX® tablets was assessed in all 4 examined colonic regions (ascending, transverse and descending colon and rectosigmoid).
The staining efficacy in each colon region was assessed scoring the observed staining percentage as reported below:
1. no staining
2. traces (poor traces in colon mucosa)
3. detectable (at least the 25% of colon mucosa is stained)
4. acceptable (at least the 50% of colon mucosa is stained)
5. good (at least the 75% of colon mucosa is stained)
6. overstained (the 100% of the colon mucosa is over stained)
Measured: During colonscopy (usually <15 min) and subsequent histological analysis
Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation
The Boston Bowel Preparation Score (BBPS) was used to rate colon cleansing quality. Each of the following 3 regions was rated: right, mid and rectosigmoid colon. The following 4-point scale (0-3) was used.
0 - unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared
1. - portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid
2. - minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well
3. - entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Each region of the colon received a "segment score" from 0 to 3 and these segment scores were summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon, without any residual liquid, is 9 and the minimum BBPS score for an unprepared colon is 0.
Measured: During colonscopy (usually <15 min)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jul 2012

First posted27 Jan 2012 (estimated)
Study startJan 2012
Primary completionJul 2012
Study completionJul 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 Ulcerative ColitisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01520324
Sponsor's protocol ID: CB-17-01/04
Status last verified: Sep 2018
First submitted: 25 Jan 2012
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.
ClinicalTrials.gov ID: NCT01520324
Acronym / sponsor ID: CB-17-01/04
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Cosmo Technologies LtdIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Posted 8 Feb 2019

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 intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with UC undergoing colonoscopy	Experimental	Device: oral delivery mucosal stain

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

endoscopically verified UC signed written informed consent

Key exclusion criteria (1 listed)

Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

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
oral delivery mucosal stain200mg methylene blue MMX tablet taken prior to colonoscopy	Device	Patients with UC undergoing colonoscopy

Primary outcome

Detected Intraepithelial Neoplasia
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
Rate of intraepithelial neoplasiae detection in the whole colon.
Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.

3 secondary outcomes

The Extent and Severity of the Inflamed Mucosa
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation.
Time frame: During colonscopy (usually <15 min) and subsequent histological analysis
Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation
Time frame: During colonscopy (usually <15 min)

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With UC Undergoing Colonoscopy	53	52

Primary outcome: Detected Intraepithelial Neoplasia

Time frame: During colonscopy (usually <15 min) and subsequent histological analysis. Mean (Standard Deviation). Unit: Number of detected IN

Measure	Full Analysis Set (FAS) n = 52
Value	0.2 (0.5)

Primary outcome: Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)

Time frame: During colonscopy (usually <15 min) and subsequent histological analysis. Number. Unit: percentage of true pos. findings of IN

Measure	Full Analysis Set (FAS) n = 52
Value	7.7

Primary outcome: Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)

Time frame: During colonscopy (usually <15 min) and subsequent histological analysis. Number. Unit: percentage of false pos. findings of IN

Measure	Full Analysis Set (FAS) n = 52
Value	7.7

Primary outcome: Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)

Time frame: During colonscopy (usually <15 min) and subsequent histological analysis. Number. Unit: percentage of true neg. findings of IN

Measure	Full Analysis Set (FAS) n = 52
Value	78.8

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: On the day before colonoscopy (day 1), the subjects took the investigational product at home during the intake of the bowel cleansing preparation according to the given instructions. On the following day (day 2), the patients returned to the clinic for colonoscopy. The investigator inquired the subjects about occurrence of any AE and the intake of concomitant medications. It was over these two days the AEs were monitored.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Analysis Set (FAS)	0 of 53 (0%)	8 of 53 (15.1%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ulcerative Colitis

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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.

Silvio Danese, MD principal investigator

Humanitas Hospital, Italy

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 oral delivery mucosal stain in people with Ulcerative Colitis, 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 1 inclusion and 1 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 8 Feb 2019. 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. 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 8 Feb 2019). 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?

Detected Intraepithelial Neoplasia (time frame: During colonscopy (usually <15 min) and subsequent histological analysis). The study lists 5 primary outcomes in all. 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 NCT01520324.

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 8 Feb 2019.