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)

Colorectal Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689792
• Other study ID #: NOR-01/2011 (PDR)
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2012
• Last updated: March 30, 2015
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• MOVIPREP

• CitraFleet

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg	Aschaffenburg

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Flat lesion only detection rate	Flat lesion only detection of the patients	at the colonoscopy	No
Secondary	Advanced risk lesion detection rate	Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous	at the colonoscopy	No
Secondary	Colonoscopy completion rate	The rate of colonoscopy completion	at the colonoscopy	No
Secondary	Colon cleansing quality	Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©	at the colonoscopy	No
Secondary	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	No