Phase 2 N=53 Diagnostic

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

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT01520324 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Detected Intraepithelial Neoplasia — 0.2 Number of detected IN

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: oral delivery mucosal stain (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cosmo Technologies Ltd
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Detected Intraepithelial Neoplasia	0.2	—
PRIMARY Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)	7.7	—
PRIMARY Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)	7.7	—
PRIMARY Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)	78.8	—
PRIMARY Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)	5.8	—
SECONDARY The Extent and Severity of the Inflamed Mucosa	2.1; 1.1	—
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.	3.4; 3.0; 2.9; 2.8	—
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	1.3; 1.7; 1.7	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01520324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.