Patients with clinical symptoms or polyp history scheduled for either a diagnostic/surveillance colonoscopy or for a screening procedure in patients with a personal or familial risk of colon neoplasia. MedDRA version: 15.0 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: MOVIPREP
Product Name: MOVIPREP
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Macrogols
CAS Number: 25322-68-3
Other descriptive name: Polyethylene glycol
Concentratio
Sponsors
Norgine Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients will not be eligible to take part in the study if: • 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 |
|---|---|
| Main Objective: To compare the polyp and adenoma detection rate of MOVIPREP® versus an oral Sodium Picosulfate/Magnesium Citrate solution ;Secondary Objective: To assess the correlation between the cleansing quality and the detection rate of the two types of bowel cleansing preparations.;Primary end point(s): Polyp detection rate (PDR,) defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist.;Timepoint(s) of evaluation of this end point: Complete enrollment of 400 patients for interim analysis (IA) and subsequent enrollment of up to 800 patients dependent on the outcome of the IA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Adenoma detection rate (ADR) defined as number of patients with at least one adenoma as confirmed by the pathologist • ADR and PDR by location: • left-sided (rectum, colon sigmoideum, colon descendens, left half of colon transversum) • right-sided (right half of colon transversum, colon ascendens, caecum) • Cancer detection rate, defined as number of patients with at least one malignancy in relation to total analysis population. • Flat lesion only detection rate. • Advanced risk lesion detection rate. • Colonoscopy completion rate. • Colon cleansing quality, as reported by the gastroenterologist, according to the Harefield Cleansing Scale©. • Acceptability and tolerability of the study medication. ;Timepoint(s) of evaluation of this end point: Complete enrollment of 400 patients for interim analysis (IA) and subsequent enrollment of up to 800 patients dependent on the outcome of the IA. | — |
Countries
Germany
Contacts
Public ContactCRO
Pierrel Research Europe GmbH
Outcome results
None listed