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

Ulcerative Colitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520324
• Other study ID #: CB-17-01/04
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2018
• Source: Cosmo Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• oral delivery mucosal stain
200mg methylene blue MMX tablet taken prior to colonoscopy

Locations

Country	Name	City	State
Italy	Centre for Research & Care of Intestinal Diseases	Rozzano

Sponsors (1)

Lead Sponsor	Collaborator
Cosmo Technologies Ltd

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detected Intraepithelial Neoplasia	Rate of intraepithelial neoplasiae detection in the whole colon.	During colonscopy (usually <15 min) and subsequent histological analysis
Primary	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.	During colonscopy (usually <15 min) and subsequent histological analysis
Primary	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.	During colonscopy (usually <15 min) and subsequent histological analysis
Primary	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.	During colonscopy (usually <15 min) and subsequent histological analysis
Primary	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.	During colonscopy (usually <15 min) and subsequent histological analysis
Secondary	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.	During colonscopy (usually <15 min) and subsequent histological analysis
Secondary	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)	During colonscopy (usually <15 min) and subsequent histological analysis
Secondary	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.	During colonscopy (usually <15 min)