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)

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norgine
• Treatments: Central Nervous System Stimulants; Citric Acid; Magnesium citrate; Picosulfate sodium

Criteria

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.