Evaluation of 2 regimens of colon preparation for advanced cleaning.
- Conditions
- Intestinal cleaning in subjects submitted to colonscopy planned between 8:00 and 10.00 a.m..MedDRA version: 21.0Level: PTClassification code 10010011Term: Colonoscopy normalSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-002565-34-IT
- Lead Sponsor
- SOCIETA' ITALIANA DI ENDOSCOPIA DIGESTIVA - SIED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 320
Outpatients of both genders that are consecutively submitted to colonscopy with the examination planned from 8:00 to 10:00 a.m..
Age between 18 and 75 years
Written informed consent
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
Hypersensitivity and controindications to study product
Either history of colon resection or bowel inflammatory disease
Previous surgery of the digestive tract
Suspected bowel drilling
Either pregnacy or lactation
Treatment with drugs which can alter bowel peristalsis
Either inability or rejection to give written informed consent
Any other clinical condition which is not compatible with the participation in this study according to the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method