Medical conditions requiring the complete emptying of large intestin. MedDRA version: 12.1 Level: PT Classification code 10066943 Term: Bowel preparation
Conditions
Interventions
Product Name: EASYGOL
Product Code: PMF104
Pharmaceutical Form: Powder for oral solution
CAS Number: 25322-68-3
Other descriptive name: MACROGOL 4000
Concentration unit: g gram(s)
Concentration type:
Sponsors
PROMEFARM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients aged between 18 - 85 years old - patients undergoing a complete 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: - known or suspected gastrointestinal obstruction or perforation - toxic megacolon - major colonic resection - heart failure (Class III o IV), serious cardiovascular disease - severe liver failure - end-stage renal insufficiency - pregnant or at risk of becoming pregnant, lactating women - known or suspected hypersensitivity to the active principles or other ingredients, history of anaphylaxis to drugs or allergic reactions in general - phenylketonuria - glucose 6-phosphate dehydrogenase deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy in patients undergoing colonoscopy.;Secondary Objective: To evaluate mucosal visibility and patients safety, tolerability, compliance and acceptance.;Primary end point(s): Bowel cleansing as assessed by the validated Ottawa scale. | — |
Countries
Austria
Outcome results
None listed