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Effect of Methylene Blue MMX on DNA Damage in Colon Biopsy
NCT02295774Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2013
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- Cosmo Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- lumeblue
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label trial of lumeblue in colorectal cancer (CRC) (2 arms), sponsored by Cosmo Pharmaceuticals. Primary endpoint: Gamma H2AX Histone Levels in Colonic Biopsy at 2 weeks. Started Feb 2013; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Standard Colonoscopy
Standard white light colonoscopy (Control)
Methylene Blue MMX Colonoscopy
Colonoscopy with prior Methylene Blue MMX administration
03
Who it enrols
Adult outpatients scheduled for screening/surveillance colonoscopy who require a second colonoscopy within 2 weeks. Excludes pregnant women, those with G6PD deficiency, severe GI or cardiovascular conditions, and those taking specific psychiatric medications or anticoagulants.
04
Endpoints
Primary
Gamma H2AX Histone Levels in Colonic Biopsy
Secondary
Staining Quality Obtained With Oral Methylene Blue MMX Tablets
Safety and Tolerability of Oral Methylene Blue MMX Tablets
Time to Reach the Caecum During Colonoscopy
Withdrawal Time from Caecum to Exit
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