Intestinal cleaning in subjects submitted to colonscopy planned between 8:00 and 10.00 a.m.. MedDRA version: 21.0 Level: PT Classification code 10010011 Term: Colonoscopy normal System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: CLENSIA
Product Name: CLENSIA
Product Code: [NA]
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: MACROGOL 4000, Sodio solfato anidro, Simeticone, Sodio citrato, Acido ci
Sponsors
SOCIETA' ITALIANA DI ENDOSCOPIA DIGESTIVA - SIED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of preparation A vs preparation B, in terms of colon cleaning, in paients submitted to colonscopy.;Secondary Objective: Evaluation of the efficacy of preparation A vs preparation B, in terms of right colon cleaning, in patients submitted to colonscopy. Evaluation of the efficacy of preparation A vs preparation B, in terms of wounds detected, in patients submitted to colonscopy. Evaluation of the efficacy of preparation A vs preparation B, in terms of mucosa visibility, in patients submitted to colonscopy. Evaluation of the efficacy of preparation A vs preparation B, in terms of compliance and acceptability, in patients submitted to colonscopy. Evaluation of the tolerability of preparation A vs preparation B in patients submitted to colonscopy. Evaluation of the safety of preparation A vs preparation B , in terms of adverse events onset, in patients submitted to colonscopy.;Primary end point(s): Percentage of colonscopies with adecuate preparation (according to BBPS score = 2) in each bowel segment, in group of patients A vs group of patients B;Timepoint(s) of evaluation of this end point: At visit 2, after the execution of colonscopy for each ptient enrolled in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number and percentage of colonscopies with adecuate preparation (according to BBPS score = 2) in right bowel, in group of patients A vs group of patients B Number of wounds detected in group of patients A vs group of patients B Amount of bubbles and/or foam according to IBS in group of patients A vs group of patients B Level of acceptatbility and compliance, through questionnaire, in group of patients A vs group of patients B Level of tolerability, through questionnaire, in group of patients A vs group of patients B Rate and entity of adverse events in group of patients A vs group of patients B;Timepoint(s) of evaluation of this end point: At visit 2, after the execution of colonscopy for each ptient enrolled in this study. | — |
Countries
Italy
Contacts
Public ContactContract Research Organization
InformaPRO srl
Outcome results
None listed