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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003983-32 | EudraCT Number |
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Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylene Blue MMX® 200mg | Active Comparator | Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule |
|
| Methylene Blue MMX® 100mg | Active Comparator | Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule |
|
| Placebo | Placebo Comparator | Oral dose, 8 Placebo tablets over a 4hr schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylene Blue MMX® | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma. | Adenoma Detection Rate | +7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, MD | Co-ordinating Investigator EU | Principal Investigator |
| Michael Wallace, MD | Co-ordinating Investigator US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Michelle Young | Phoenix | Arizona | 85012 | United States | ||
| Dr Francesco Ramirez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30742834 | Derived | Repici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylene Blue MMX® 200mg | Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule Methylene Blue MMX® |
| FG001 | Methylene Blue MMX® 100mg | Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule Methylene Blue MMX® Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Sugar pill manufactured to mimic Methylene Blue MMX® tablet. |
|
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Dr David Gatof | Lafayette | Colorado | 80026 | United States |
| Dr Michael Wallace | Jacksonville | Florida | 32224 | United States |
| Dr Prateek Sharma | Kansas City | Kansas | 66103 | United States |
| Dr Marcia Canto | Baltimore | Maryland | 21287 | United States |
| Dr David Bruining | Rochester | Minnesota | 55905 | United States |
| Dr Raf Bisschop | Leuven | Belgium |
| Dr Norman Marcon | Toronto | Ontario | M5B 1W8 | Canada |
| Dr Ralf Kiesslich | Wiesbaden | Germany |
| Dr Renato Cannizzaro | Aviano | Italy |
| Dr Cesare Hassan | Rome | Italy |
| Dr Alessandro Repici | Rozzano | Italy |
| Dr Limas Kupcinskas | Kaunas | Lithuania |
| Dr Evelien Dekker | Amsterdam | Netherlands |
| Dr Manoon Spander | Rotterdam | Netherlands |
| Dr Peter Siersema | Utrecht | Netherlands |
| Dr James East | Oxford | United Kingdom |
| Dr Matthew Rutter | Stockton-on-Tees | United Kingdom |
| FG002 | Placebo | Oral dose, 8 Placebo tablets over a 4hr schedule Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylene Blue MMX® 200mg | Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule Methylene Blue MMX® |
| BG001 | Methylene Blue MMX® 100mg | Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule Methylene Blue MMX® Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. |
| BG002 | Placebo | Oral dose, 8 Placebo tablets over a 4hr schedule Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | ITT=1249, FAS=1205 | Count of Participants | Participants | No |
| |||||||||
| Sex: Female, Male | ITT=1249 FAS=1205 | Count of Participants | Participants |
|
| 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 | To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma. | Adenoma Detection Rate | FAS | Posted | Number | percentage of participants | +7 days |
|
|
|
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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 | Methylene Blue MMX® 200mg | Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule Methylene Blue MMX® | 1 | 485 | 234 | 488 | ||
| EG001 | Methylene Blue MMX® 100mg | Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule Methylene Blue MMX® Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. | 1 | 241 | 102 | 241 | ||
| EG002 | Placebo | Oral dose, 8 Placebo tablets over a 4hr schedule Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. | 0 | 479 | 7 | 479 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| viral bronchitis | Infections and infestations |
| |||
| haematochezia | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| faeces discoloured | Gastrointestinal disorders |
| |||
| chromaturia | Renal and urinary disorders |
|
Publications to be reviewed by sponsor prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R&D Manager | Cosmo Technologies Ltd | 111111111 | 11111 | rjones@cosmopharma.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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