Phase 3
N=1,249
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01694966 ↗Enrolled (actual)
1,249
Serious AEs
0.2%
Results posted
Nov 2017
Primary outcome: 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. — 56.3; 51.5; 47.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methylene Blue MMX® (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Cosmo Technologies Ltd
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
56.3; 51.5; 47.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01694966). 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.