A Multi-centre 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)

Norgine

Status and phase

Completed

Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: CitraFleet

Drug: MOVIPREP

Study type

Interventional

Funder types

Industry

Identifiers

NOR-01/2011 (PDR)

Details and patient eligibility

About

To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.

Enrollment

398 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

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.