colorectal cancer MedDRA version: 15.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: ISOCOLAN*8BUST 34,8G+CONTENITO
Pharmaceutical Form: Oral powder
INN or Proposed INN: MACROGOL 4000
CAS Number: 8000014-43-9
Concentration unit: g gram(s)
Concentration type: equal
Concentr
Sponsors
ISTITUTO ONCOLOGICO VENETO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects invited to undergo a first total colonoscopy after a positive fecal occult blood test performed in a colorectal screening programme 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 2200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: Post-polypectomy colonoscopy, repeat colonoscopy after an incomplete one, etc. Subjects who cannot give an informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the efficacy of three medicines in terms of bowel cleansing;Secondary Objective: To evaluate the patients’ compliance and satisfaction about the three medicines;Primary end point(s): Bowel cleansing;Timepoint(s) of evaluation of this end point: The end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patients’ compliance and satisfaction;Timepoint(s) of evaluation of this end point: The end of the study. | — |
Countries
Italy
Contacts
Public ContactRegistro Tumori del Veneto
Istituto Oncologico Veneto
Outcome results
None listed