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

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Device: oral delivery mucosal stain

• Registration Number: NCT01520324
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-27
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2017-11-30
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Results First Posted: 2019-02-08
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with UC undergoing colonoscopy	oral delivery mucosal stain	-

Primary Outcome Measures

Name	Time	Method
Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)	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 Positive Findings)	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)	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)	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.
Detected Intraepithelial Neoplasia	During colonscopy (usually <15 min) and subsequent histological analysis	Rate of intraepithelial neoplasiae detection in the whole colon.

Secondary Outcome Measures

Name	Time	Method
The Extent and Severity of the Inflamed Mucosa	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.
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.	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)
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	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.

Trial Locations

Locations (1)

Centre for Research & Care of Intestinal Diseases; 🇮🇹 Rozzano, Italy