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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.
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.
Details
| Lead sponsor | Cosmo Technologies Ltd |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 53 |
| Start date | 2012-01 |
| Completion | 2012-07 |
Conditions
- Ulcerative Colitis
Interventions
- oral delivery mucosal stain
Primary outcomes
- Detected Intraepithelial Neoplasia — During colonscopy (usually <15 min) and subsequent histological analysis
Rate of intraepithelial neoplasiae detection in the whole colon. - 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. - 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.
Countries
Italy