Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGMethylene Blue MMX®
DRUGPlacebo
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Sponsors
Cosmo Technologies Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females, aged between 50 and 75. * Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer ) * Able to comprehend the full nature and purpose of the study, including possible risks and side effects. * Able to co-operate with the investigator and to comply with the requirements of the entire study. * Signed written informed consent prior to inclusion in the study.
Exclusion criteria
* Patients at high risk of colorectal cancer e.g. ulcerative colitis * Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients. * Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients. * Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | +7 days | Adenoma Detection Rate |
Countries
Belgium, Canada, Germany, Italy, Lithuania, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methylene Blue MMX® 200mg Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX® | 504 |
| 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. | 247 |
| Placebo Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet. | 498 |
| Total | 1,249 |
Baseline characteristics
| Characteristic | Methylene Blue MMX® 200mg | Methylene Blue MMX® 100mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 172 Participants | 78 Participants | 181 Participants | 431 Participants |
| Age, Categorical Between 18 and 65 years | 313 Participants | 163 Participants | 298 Participants | 774 Participants |
| Sex: Female, Male Female | 191 Participants | 103 Participants | 184 Participants | 478 Participants |
| Sex: Female, Male Male | 294 Participants | 138 Participants | 295 Participants | 727 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 234 / 488 | 102 / 241 | 7 / 479 |
| serious Total, serious adverse events | 1 / 485 | 1 / 241 | 0 / 479 |
Outcome results
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
Time frame: +7 days
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methylene Blue MMX® 200mg | 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. | 56.3 percentage of participants |
| Methylene Blue MMX® 100mg | 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. | 51.5 percentage of participants |
| Placebo | 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. | 47.8 percentage of participants |