A multi-centre, randomised, investigator-blinded study comparing the polyp detection rate of two different types of bowel preparation: a 2-litre solution (MOVIPREP®) versus a hyperosmotic and stimulant combined low volume bowel preparation (Sodium Picosulfate and Magnesium Citrate) - MOVIPREP versus Sodium Picosulfate & Magnesium Citrate in polyp detection

orgine Limited0 个研究点开始时间: 2011年8月5日最近更新: 2014年11月24日

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•Inclusion Criteria:
•Patient’s written informed consent must be obtained prior to inclusion
•Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy
•Willing to undergo a colonoscopy for diagnostic or surveillance purposes
•Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy
•Willing, able and competent to complete the entire procedure and to comply with study instructions
•Females of childbearing potential must employ an adequate method of contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 800
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion Criteria:
•Patients will not be eligible to take part in the study if:
•History of gastric emptying disorders.
•History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
•History of phenylketonuria.
•Known glucose-6-phosphate dehydrogenase deficiency.
•Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
•History of colonic resection.
•Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).
•Presence of congestive heart failure (NYHA III + IV).
•Acute life-threatening cardiovascular disease.
•Documented history of severe renal insufficiency (creatinine clearance <30 ml/min).
•Other contraindication described in the summary of product characteristics (SmPC) of either preparation.
•Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.
•Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.
•Females who are pregnant, nursing or planning a pregnancy.
•Patients who, in the opinion of the investigator, may not be compliant with the study requirements.
•Previous participation in this clinical study.

发起方

orgine Limited