Colorectal Cancer
Conditions
Brief summary
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.
Interventions
DRUGMOVIPREP
DRUGCitraFleet
Sponsors
Norgine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Advanced risk lesion detection rate | at the colonoscopy | Advanced risk lesion detection rate (lesions \>1 cm, low grade and/or villous |
Countries
Germany
Outcome results
None listed