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

2014-08-27 03:16:01 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Conditions

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

Intervention

Sodium picosulphate, light magnesium oxide and anhydride citric acid., Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.

Location

H. Infanta Elena
Valdemoro
Madrid
Spain
28340

Status

Recruiting

Source

Laboratorios Casen-Fleet S.L.U.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:01-0400

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