Track topics on Twitter Track topics that are important to you
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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
Sodium picosulphate, light magnesium oxide and anhydride citric acid., Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
H. Infanta Elena
Laboratorios Casen-Fleet S.L.U.
Published on BioPortfolio: 2014-08-27T03:16:01-0400
The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing col...
The objective ot the study is to compare the efficacy and safety of 4 weeks treatment with sodium picosulphate drops 10mg to placebo in patients with functional constipation. In addition t...
Efficacy and Safety Clinical Trial of the Combination of Acetylsalicylic Acid, Sodium Bicarbonate and Citric Acid, Produced by Geolab Pharmaceutical Industries Ltd., Compared to Acetylsalicylic Acid (Aspirin ® - Bayer) in Patients With Episodic Tension-t
This study aims is to evaluate, two hours after a single administration, the rate of sustained response produced by the association Geolab consisting of acetylsalicylic acid, sodium bicarb...
This study will test the hypothesis that by slightly lowering the acidity of blood (or increasing the pH), dialysis patients utilize protein and amino acids more efficiently.
This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are ...
Effects of the food additives sodium acid pyrophosphate, sodium acetate, and citric acid on hemato-immunological pathological biomarkers in rats: Relation to PPAR-α, PPAR-γ and tnfα signaling pathway.
The food additives sodium acid pyrophosphate (SAPP), sodium acetate (SA), and citric acid (CA) were evaluated for their hemato-immunotoxic effects. Forty adult Sprague-Dawley rats were distributed int...
Bowel Preparation for Gastrointestinal Endoscopic Procedures With Sodium Picosulphate-Magnesium Citrate Is an Effective, Safe, and Well-Tolerated Option in Pediatric Patients: A Single-Center Experience.
To obtain optimal visualization of the colonic mucosa during gastrointestinal endoscopic procedures, an adequate bowel preparation is mandatory, but a standardized protocol is still lacking for pediat...
The physical strength of the collagen fibre network in the extracellular matrix is due to the covalent crosslinks between the molecules within the fibres (intra-fibrillar crosslinks). Citric acid was ...
Magnesium is an element of great importance functioning because of its association with many cellular physiological functions. The magnesium content of foods is gradually decreasing due to food proces...
Nisin is a known bacteriocin approved as a food additive for food preservation. It exhibits a wide spectrum antimicrobial activity against Gram-positive bacteria. Iron oxide magnetic nanoparticles wer...
Magnesium oxide (MgO). An inorganic compound that occurs in nature as the mineral periclase. In aqueous media combines quickly with water to form magnesium hydroxide. It is used as an antacid and mild laxative and has many nonmedicinal uses.
A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
A material used for cementation of inlays, crowns, bridges, and orthodontic appliances and occasionally as a temporary restoration. It is prepared by mixing zinc oxide and magnesium oxide powders with a liquid consisting principally of phosphoric acid, water, and buffers. (From Bouchers' Clinical Dental Terminology, 3d ed)
A dicarboxylic acid ketone that is an important metabolic intermediate of the CITRIC ACID CYCLE. It can be converted to ASPARTIC ACID by ASPARTATE TRANSAMINASE.
An enzyme that catalyzes the reversible hydration of fumaric acid to yield L-malic acid. It is one of the citric acid cycle enzymes. EC 220.127.116.11.
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...
Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...