Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01520324Other idCB-17-01/04

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Methylene blue, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 53 participants (actual)
Sponsor: Cosmo Technologies Ltd · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Italy
Start: Jan 2012
Primary completion: Jul 2012
Completion: Jul 2012
First posted: 27 Jan 2012 (estimated)
Last update posted: 8 Feb 2019
Conditions: Ulcerative Colitis

Timeline

1 trial · 1 completed · 1 with posted results

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

20122013

Ph 2
Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy
NCT01520324
Jan 2012 to Jul 2012

Registry summary

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

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.

Interventions

oral delivery mucosal stainDevice

Arms1

Experimental
Patients with UC undergoing colonoscopy

Primary outcomes5

Outcomes the sponsor listed as primary.

Detected Intraepithelial Neoplasia
Time frame · During colonscopy (usually <15 min) and subsequent histological analysis
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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.

Secondary outcomes(3)

The Extent and Severity of the Inflamed Mucosa
Time frame · During colonscopy (usually <15 min) and subsequent histological analysis
Registry description
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.
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
Registry description
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: 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)
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)
Registry description
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.

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 outcomeMean· During colonscopy (usually <15 min) and subsequent histological analysis

Detected Intraepithelial Neoplasia

Group	Value (Number of detected IN)	Spread
Full Analysis Set (FAS)	0.2	0.5

Primary outcomeNumber· During colonscopy (usually <15 min) and subsequent histological analysis

Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)

Group	Value (percentage of true pos. findings of IN)
Full Analysis Set (FAS)	7.7

Primary outcomeNumber· During colonscopy (usually <15 min) and subsequent histological analysis

Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)

Group	Value (percentage of false pos. findings of IN)
Full Analysis Set (FAS)	7.7

Primary outcomeNumber· During colonscopy (usually <15 min) and subsequent histological analysis

Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)

Group	Value (percentage of true neg. findings of IN)
Full Analysis Set (FAS)	78.8

Primary outcomeNumber· During colonscopy (usually <15 min) and subsequent histological analysis

Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)

Group	Value (percentage of false neg. findings of IN)
Full Analysis Set (FAS)	5.8

Secondary and other outcome results(3)

Secondary outcomeMean· During colonscopy (usually <15 min) and subsequent histological analysis

The Extent and Severity of the Inflamed Mucosa

Group	Value (Rachmilewitz and Saverymuttu scores)	Spread
Full Analysis Set (FAS)	2.1	3.0

Secondary outcomeMean· 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.

Group	Value (Staining score)	Spread
Full Analysis Set (FAS)	3.4	1.0

Secondary outcomeMean· During colonscopy (usually <15 min)

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

Group	Value (Boston bowel preparation scale (BBPS))	Spread
Full Analysis Set (FAS)	1.3	0.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Full Analysis Set (FAS)All enrolled subjects, who received at least one dose of the test investigational medicinal product and had at least one evaluation of the number of detected neoplasiae.	0 / 53	0 / 53	8 / 53

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.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * endoscopically verified UC signed written informed consent Exclusion Criteria: * Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

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