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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with UC undergoing colonoscopy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral delivery mucosal stain | Device | 200mg methylene blue MMX tablet taken prior to colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detected Intraepithelial Neoplasia | Rate of intraepithelial neoplasiae detection in the whole colon. | During colonscopy (usually <15 min) and subsequent histological analysis |
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvio Danese, MD | Humanitas Hospital, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Research & Care of Intestinal Diseases | Rozzano | 20089 | Italy |
This was an exploratory, non-comparative study with no randomization. All subjects were allocated to receive Selg 1000® 4 L bowel preparation, the day before colonoscopy. All study subjects were allocated to receive 200 mg of Methylene Blue MMX® tablets during and at the end of the intake of bowel cleansing preparation.
This study recruited patients with a diagnosis of ulcerative colitis dating not less than 8 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With UC Undergoing Colonoscopy | oral delivery mucosal stain: 200mg methylene blue MMX tablet taken prior to colonoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With UC Undergoing Colonoscopy | oral delivery mucosal stain: 200mg methylene blue MMX tablet taken prior to colonoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 18 <= age years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Detected Intraepithelial Neoplasia | Rate of intraepithelial neoplasiae detection in the whole colon. | Posted | Mean | Standard Deviation | Number of detected IN | During colonscopy (usually <15 min) and subsequent histological analysis |
|
|
On the day before colonoscopy (day 1), the subjects took the investigational product at home during the intake of the bowel cleansing preparation according to the given instructions. On the following day (day 2), the patients returned to the clinic for colonoscopy. The investigator inquired the subjects about occurrence of any AE and the intake of concomitant medications. It was over these two days the AEs were monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full Analysis Set (FAS) | All enrolled subjects, who received at least one dose of the test investigational medicinal product and had at least one evaluation of the number of detected neoplasiae. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment | Mild nausea for 6 subject s Moderate for 2 subjects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Jones | Cosmo Pharmaceuticals NV | +353 18170370 | RJones@cosmopharma.com |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| During colonscopy (usually <15 min) and subsequent histological analysis |
| During colonscopy (usually <15 min) and subsequent histological analysis |
| 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
| During colonscopy (usually <15 min) and subsequent histological analysis |
| 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
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) |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body weight | Mean | Standard Deviation | kg |
|
|
|
| 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. | Posted | Number | percentage of true pos. findings of IN | 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. | Posted | Number | percentage of false pos. findings of IN | 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. | Posted | Number | percentage of true neg. findings of IN | 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. | Posted | Number | percentage of false neg. findings of IN | 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. | Posted | Mean | Standard Deviation | Rachmilewitz and Saverymuttu scores | 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
| Posted | Mean | Standard Deviation | Staining score | 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
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. | Posted | Mean | Standard Deviation | Boston bowel preparation scale (BBPS) | During colonscopy (usually <15 min) |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 8 |
| 53 |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment | Mild |
|
Publication to be reviewed by sponsor prior to submission.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Title | Measurements |
|---|---|
|
| Rectosigmoid |
|
| Title | Measurements |
|---|---|
|