Patients with indications to undergoing a complete colonoscopy MedDRA version: 14.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: SELG*OS POLV 4BUST 70G 1LT
Pharmaceutical Form: Oral powder
INN or Proposed INN: Macrogol, combinations
Concentration unit: g gram(s)
Concentration number: 58.3-
Trade Name: LOVOLDYL*30CP
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and females patients; Aged between 18 and 85 years; Indications to undergoing a complete colonoscopy Are the trial subjects under 18? no Number of subjects for this age range: 0 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; Major colonic resection; Toxic megacolon; Pregnant or lactating women or at a risk of becoming pregnant; Known or suspected hypersensitivity to the active principle and/or formulations' ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the efficacy and tolerability of low-volume bowel preparation taken the same day vs split dose bowel preparations.;Secondary Objective: Comparison of feasibility and patient satisfaction and compliance of bowel preparations.;Primary end point(s): Evaluation of the overall quality of bowel preparation using the validated Ottawa scale. | — |
Countries
Italy
Outcome results
None listed