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

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ClinicalTrials.gov Identifier: NCT01520324
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
CosmoTech ( Cosmo Technologies Ltd )

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: oral delivery mucosal stain Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with UC undergoing colonoscopy Device: oral delivery mucosal stain
200mg methylene blue MMX tablet taken prior to colonoscopy




Primary Outcome Measures :
  1. Detected Intraepithelial Neoplasia [ Time Frame: During colonscopy (usually <15 min) and subsequent histological analysis ]
    Rate of intraepithelial neoplasiae detection in the whole colon.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. The Extent and Severity of the Inflamed Mucosa [ Time Frame: During colonscopy (usually <15 min) and subsequent histological analysis ]

    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.


  2. 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 ]

    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)

  3. 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) ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520324


Locations
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Italy
Centre for Research & Care of Intestinal Diseases
Rozzano, Italy, 20089
Sponsors and Collaborators
Cosmo Technologies Ltd
Investigators
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Principal Investigator: Silvio Danese, MD Humanitas Hospital, Italy

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Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01520324     History of Changes
Other Study ID Numbers: CB-17-01/04
First Posted: January 27, 2012    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019
Last Verified: September 2018
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action