Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.

Study Overview
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Brief Summary
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The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.

Detailed Description
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The composite principal objective of the current study will therefore be, to determine any significant differences in the joint variable of efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a colon examination. The evaluation will be carried out by two blinded assessors, independent of the investigator who performed the procedure (endoscopist investigator). It will be assessed from images of different sections of the colon: cecum, ascending, transverse, descending and rectum and subsequent confirmation by Principal Investigator if an agreement has been reached between the two blinded assessors or whether it is necessary to reach consensus. The evaluation of the subject's acceptability will be assessed using a 5 point scale which assesses the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug. The secondary objective is to evaluate the safety of CitraFleet. In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet Exploratory arm). The study is not powered to make formal statistical comparisons for this arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep will be made in order to run future trials design with this schedule.

Official Title
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Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.

Conditions
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Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.

Intervention / Treatment
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* Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.
* Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are between 18 and 80 years of age. Subjects undergoing complete colonoscopy and therefore require prior preparation with either Klean Prep® or CitraFleet. Subjects capable of maintaining appropriate oral hydration during the intestinal preparation process. Subjects that have provided written informed consent. Subjects in whom the use of any of the study drugs (KleanPrep®,CitraFleet) is not contraindicated. Subjects who can communicate with the study personnel and comply with study requirements. Subjects undergoing a complete exploratory diagnostic colonoscopy for the first time. Exclusion Criteria: Severe renal insufficiency. Ascites. Congestive heart failure. Gastrointestinal obstruction, gastric retention, intestinal perforation and/or ileus. Megacolon and/or toxic colitis. Nausea and/or vomiting and/or abdominal pain. Severe dehydration. Hypermagnesemia. Rhabdomyolysis. Pregnant women. Subjects who have participated in a clinical trial in the previous 30 days. Abdominal surgery for any acute process (for example acute appendicitis). Active inflammatory intestinal disease. Known allergy to any of the active ingredients or excipients of the study drugs. Subjects not providing written informed consent. Subjects not complying with all of the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrafleet<br>The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h. | Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.<br>* 2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).<br>* Other names: Citrafleet;|
| Active Comparator: Klean Prep<br>The day prior to the colonoscopy from 16:00h to 20:00h. | Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.<br>* 4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr).<br>* Other names: KleanPrep PEG 4l;|
| Experimental: Citrafleet Exploratory<br>The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h. | Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.<br>* 2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).<br>* Other names: Citrafleet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing. |  | 24 hours | 
| Percentage of subjects who find the agent easy to take or tolerable using a 5 point scale which assesses, the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug, recorded in the subject questionnaire |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse reactions. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Preparation, Evacuating, Bowel Cleansing.