Phase 2
Completed N=53
Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy
Source: ClinicalTrials.gov NCT01520324 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Detected Intraepithelial Neoplasia — 0.2 Number of detected IN
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.
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 | — |
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.
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. Informational only — not medical advice.