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Methylene Blue MMX for Adenoma Detection in Colonoscopy
NCT01694966Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2013
- Primary completion
- Oct 2016
- Countries
- 8
- Sponsor
- Cosmo Pharmaceuticals
- Drugs
- lumeblue
- Conditions
- colorectal cancer (CRC)adenomatous polyp
01
Overview
Phase 3, randomised, double-blind trial of lumeblue in colorectal cancer (CRC) and adenomatous polyp (3 arms), sponsored by Cosmo Pharmaceuticals. Primary endpoint: Adenoma Detection Rate at 7 days. Started Sep 2013; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Methylene Blue MMX 200mg
8 Methylene Blue MMX 25mg tablets
Methylene Blue MMX 100mg
4 Methylene Blue MMX 25mg tablets and 4 Placebo tablets
Placebo
8 Placebo tablets
03
Who it enrols
Adults aged 50-75 scheduled for screening or surveillance colonoscopy, excluding those with high risk of colorectal cancer (e.g., ulcerative colitis) or significant gastrointestinal and cardiovascular comorbidities.
04
Endpoints
Primary
Adenoma Detection Rate
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