Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

Study Overview
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Brief Summary
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Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs split regimen (B) of Clensia, in patients undergoing endoscopy.

Detailed Description
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Enrolled patients, after providing written informed consent, are randomized to the CLENSIA preparation scheme, delayed full-dose or split-dose regimen. The delayed full-dose regimen will constitute study arm A while the split-dose regimen will constitute the control arm B. Participants will follow a slag-free diet in the three days preceding the colonoscopy (reduction in the consumption of fruit, vegetables and legumes). On the day before the colonoscopy, patients will be able to have a normal breakfast and lunch that are both free of fiber. The dietary indications will be delivered in writing to the patient by the health staff of the center involved in the trial. From the moment the preparation begins with the intake of the product, the intake of solid foods will no longer be allowed while clear liquids of the patient's choice can be taken freely up to two hours before the colonoscopy. The study ends for each patient with the execution of each procedure / examination planned for the visit 2 The effectiveness of the preparation in terms of intestinal cleansing is assessed blindly (by the endoscopist) using the scale (Boston Bowel Preparation Scale).

Official Title
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Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose
* Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male / female patients outpatient, consecutively subjected to colonoscopy with an exam scheduled from 8.00 to 10.00 Age between 18 and 75 years Written informed consent Exclusion Criteria: Hypersensitivity and contraindications to the product under study, to the active ingredients or to any of the excipients. Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) <30 ml / min / 1.73 m2) Presence of known chronic inflammatory bowel disease Previous digestive tract surgery Suspected gastrointestinal perforation History of congestive heart failure (NYHA class III or IV) Severe hepatic insufficiency or impairment (in the case of Child-Pugh Class C accurate verification of the patient's condition) indicated by transaminase values greater than 3 times the maximum normal value. Toxic colitis or toxic megacolon Suspected intestinal obstruction Patients enrolled in colorectal cancer screening programs Intestinal paralysis Documented electrolyte disturbances (Na, Cl, K, Ca or P outside normal limits) Recent symptomatic acute ischemic heart disease (<6 months). Acute myocardial infarction and recent unstable angina within six months antecedents. Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug, whichever is longer. Documented state of pregnancy ascertained through positive pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups randomized 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: full dose<br>Group A delayed full-dose regimen (study arm): intake of two large A sachets and 2 small B sachets from 20:30 to 22:00 the evening before the exam. Taking the remaining 2 envelopes A large e 2 small B envelopes from 10.30 pm to midnight the evening before the exam. | Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose<br>* Taking the colonoscopy preparation drug (Clensia) in a single administration<br>* Other names: Clensia in full dose;|
| Other: split dose<br>Group B split-dose regimen (control arm): intake of two large A sachets and two small B sachets from 20.30 to 22:00 the evening before the exam. The remaining two large A envelopes and two small B envelopes will be taken 5 hours earlier than the time when the exam is scheduled on the same day as the exam. | Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose<br>* Taking the colonoscopy preparation drug (Clensia) in two stages of administration<br>* Other names: Clensia in Split dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of colonoscopies with adequate preparation | Percentage of colonoscopies with adequate preparation (according to BBPS score ≥ 2) in each colonic segment, in patient group A vs patient group B | 1 day - the day of the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of bubbles | Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B | 1 day - the day of the colonoscopy | 
| tollerability and compliance | Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B | 2 days - the day of the drug administration + the day of the colonoscopy |