A study to compare the polyp (tissue mass in the gut) detection rate after bowel cleansing using 2 different types of preparatio

• Conditions: 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: 15.0Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-002364-25-DE
• Lead Sponsor: orgine Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-05
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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:
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): • Adenoma detection rate (ADR) defined as number of patients with at least one adenoma as confirmed by the pathologist <br>• ADR and PDR by location: <br>• left-sided (rectum, colon sigmoideum, colon descendens, left half of colon transversum)<br>• right-sided (right half of colon transversum, colon ascendens, caecum)<br>• Cancer detection rate, defined as number of patients with at least one malignancy in relation to total analysis population.<br>• Flat lesion only detection rate.<br>• Advanced risk lesion detection rate.<br>• Colonoscopy completion rate.<br>• Colon cleansing quality, as reported by the gastroenterologist, according to the Harefield Cleansing Scale©.<br>• Acceptability and tolerability of the study medication.<br>;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.