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Completed

NCT Number: NCT01520324

Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC 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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre for Research & Care of Intestinal Diseases

Rozzano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral delivery mucosal stain

Device

200mg methylene blue MMX tablet taken prior to colonoscopy

Primary outcomes

  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 outcomes

  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:

    • 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)

  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

    • - 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.

Sponsors and collaborators

Lead sponsor

Cosmo Technologies Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2012
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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