indication for colonoscopy
Conditions
Interventions
Product Name: Methylene blue MMX 25 mg, modified release tablets
Product Code: CB-17-01
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Methylthioninium Chloride
Concentration unit:
Sponsors
COSMO TECHNOLOGIES LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - males and females patients - aged 18-70 years - patiens with indication for colonoscopy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnancy, lactation and women at risk of becoming pregnant - Known or suspected hypersensitivity to the active principle and/or formulation ingredients - grastrointestinal obstruction or perforation, toxic megacolon, inflammatory bowel diseases - serious cardiovascular diseases, severe liver failure and renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe and evaluate the mucosal staining efficacy of methylene blue MMX 25mg modified tablets after single oral doses of 150 or 200mg in patients undergoing a full colonoscopy for various reasons.;Secondary Objective: none;Primary end point(s): To evaluate the mucosal staining efficacy of methylene blue MMX 25mg modified release tablets after single oral doses of 150 or 200mg | — |
Countries
Italy
Outcome results
None listed