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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
oral delivery mucosal stain
Sponsored by
Cosmo Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Research & Care of Intestinal Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with UC undergoing colonoscopy

Arm Description

Outcomes

Primary Outcome Measures

Detected Intraepithelial Neoplasia
Rate of intraepithelial neoplasiae detection in the whole colon.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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: 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)
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 - 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 - minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well - 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.

Full Information

First Posted
January 25, 2012
Last Updated
September 11, 2018
Sponsor
Cosmo Technologies Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01520324
Brief Title
Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cosmo Technologies Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with UC undergoing colonoscopy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
oral delivery mucosal stain
Intervention Description
200mg methylene blue MMX tablet taken prior to colonoscopy
Primary Outcome Measure Information:
Title
Detected Intraepithelial Neoplasia
Description
Rate of intraepithelial neoplasiae detection in the whole colon.
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Title
Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)
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.
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Title
Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)
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.
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Title
Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)
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.
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Title
Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)
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.
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Secondary Outcome Measure Information:
Title
The Extent and Severity of the Inflamed Mucosa
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.
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Title
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.
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 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)
Time Frame
During colonscopy (usually <15 min) and subsequent histological analysis
Title
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
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 - 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 - minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well - 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.
Time Frame
During colonscopy (usually <15 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD
Organizational Affiliation
Humanitas Hospital, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Research & Care of Intestinal Diseases
City
Rozzano
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

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

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