Bowel cleansing prior to colonoscopy MedDRA version: 9.1 Level: HLT Classification code 10017963 Term: Gastrointestinal and abdominal imaging procedures
Conditions
Interventions
Product Code: PMF104
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Macrogol, combinations
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 60.9-
Trad
Sponsors
PROMEFARM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In-patients and out-patients of both sexes aged between 18 and 85 yr undergoing a complete colonoscopy for various reasons. 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: serious gastrointestinal disease; serious cardiovascular disease, severe liver failure; end-stage renal insufficiency; pregnant or at risk of becoming pregnant, lactating women; hypersensitivity to the active principles or other ingredients; history of anaphylaxis or allergic reactions in general;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the efficacy of PMF104 in comparison with the marketed reference SELG 1000;Secondary Objective: to assess the safety, tolerability, acceptance and compliance of PMF104;Primary end point(s): Quality of bowel preparation | — |
Countries
Italy
Outcome results
None listed