Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time. Clinical Trial
Official title:
Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)