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)

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)

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: CitraFleet; Drug: MOVIPREP

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, Am Hasenkopf 1
    • Klinikum Aschaffenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CitraFleet; Administration of CitraFleet	Drug: CitraFleet
Experimental: MOVIPREP; Administration of MOVIPREP	Drug: MOVIPREP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate	Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist	At colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate (ADR)	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	At the Colonoscopy
ADR and PDR by location	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	at the colonoscopy
Cancer detection rate	Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population	at the colonoscopy
Flat lesion only detection rate	Flat lesion only detection of the patients	at the colonoscopy
Advanced risk lesion detection rate	Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous	at the colonoscopy
Colonoscopy completion rate	The rate of colonoscopy completion	at the colonoscopy
Colon cleansing quality	Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©	at the colonoscopy
Acceptability and tolerability of medication using patient questionnaires	The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires	Throughout the study

Collaborators and Investigators

• Sponsor: Norgine
• Investigators: Principal Investigator: Wolfgang Fishbach, MD, Klinikum Aschaffenburg-Alzenau

Publications and helpful links

General Publications

• Pohl J, Halphen M, Kloess HR, Fischbach W. Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study. PLoS One. 2015 May 7;10(5):e0126067. doi: 10.1371/journal.pone.0126067. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NOR-01/2011 (PDR)