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)

Phase 4

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: MOVIPREP; Drug: CitraFleet

• Registration Number: NCT01689792
• Lead Sponsor: Norgine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Primary Completion: 2013-01
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOVIPREP	MOVIPREP	Administration of MOVIPREP
CitraFleet	CitraFleet	Administration of CitraFleet

Primary Outcome Measures

Name	Time	Method
Polyp detection rate	At colonoscopy	Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist

Secondary Outcome Measures

Name	Time	Method
Adenoma Detection Rate (ADR)	At the Colonoscopy	ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population
ADR and PDR by location	at the colonoscopy	ADR and PDR by location: * left sided (rectum, colon sigmoideum, colon decendens, left half of colon transversum; * right-sided (right half of colon transversum, colon ascendens, caecum
Cancer detection rate	at the colonoscopy	Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population
Flat lesion only detection rate	at the colonoscopy	Flat lesion only detection of the patients
Advanced risk lesion detection rate	at the colonoscopy	Advanced risk lesion detection rate (lesions \>1 cm, low grade and/or villous
Colonoscopy completion rate	at the colonoscopy	The rate of colonoscopy completion
Colon cleansing quality	at the colonoscopy	Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©
Acceptability and tolerability of medication using patient questionnaires	Throughout the study	The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires

Trial Locations

Locations (1)

Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany