Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
- Conditions
- Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
- Interventions
- Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
- Registration Number
- NCT01065857
- Lead Sponsor
- Laboratorios Casen-Fleet S.L.U.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 547
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Citrafleet Sodium picosulphate, light magnesium oxide and anhydride citric acid. The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h. Klean Prep Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate. The day prior to the colonoscopy from 16:00h to 20:00h. Citrafleet Exploratory Sodium picosulphate, light magnesium oxide and anhydride citric acid. The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Frequency of adverse reactions. 24 hours
Trial Locations
- Locations (15)
H. Universitario Puerta de Hierro
🇪🇸Madrid, Spain
H. Universitario La Fé
🇪🇸Valencia, Spain
H. Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
H. Infanta Elena
🇪🇸Valdemoro, Madrid, Spain
H. Universitari Vall´d Hebron
🇪🇸Barcelona, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
H. General Universitario Reina Sofía
🇪🇸Córdoba, Spain
H. Clínic
🇪🇸Barcelona, Spain
H. Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
H. Regional Universitario Carlos Haya
🇪🇸Málaga, Spain
H. Virgen Macarena
🇪🇸Sevilla, Spain
H. Universitario Central de Asturias
🇪🇸Oviedo, Spain
H. Universitario Virgen de las Nieves
🇪🇸Granada, Spain
H. General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
H. Basurto
🇪🇸Bilbao, Vizcaya, Spain