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)
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ClinicalTrials.gov Identifier: NCT01689792 |
Recruitment Status :
Completed
First Posted : September 21, 2012
Last Update Posted : March 31, 2015
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer | Drug: MOVIPREP Drug: CitraFleet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 398 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Screening |
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) |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: CitraFleet
Administration of CitraFleet
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Drug: CitraFleet |
Experimental: MOVIPREP
Administration of MOVIPREP
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Drug: MOVIPREP |
- Polyp detection rate [ Time Frame: At colonoscopy ]Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
- Adenoma Detection Rate (ADR) [ Time Frame: 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
- ADR and PDR by location [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at the colonoscopy ]Flat lesion only detection of the patients
- Advanced risk lesion detection rate [ Time Frame: at the colonoscopy ]Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous
- Colonoscopy completion rate [ Time Frame: at the colonoscopy ]The rate of colonoscopy completion
- Colon cleansing quality [ Time Frame: 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 [ Time Frame: Throughout the study ]The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689792
Germany | |
Klinikum Aschaffenburg | |
Aschaffenburg, Germany, Am Hasenkopf 1 |
Principal Investigator: | Wolfgang Fishbach, MD | Klinikum Aschaffenburg-Alzenau |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Norgine |
ClinicalTrials.gov Identifier: | NCT01689792 History of Changes |
Other Study ID Numbers: |
NOR-01/2011 (PDR) |
First Posted: | September 21, 2012 Key Record Dates |
Last Update Posted: | March 31, 2015 |
Last Verified: | December 2013 |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Magnesium citrate |
Picosulfate sodium Citric Acid Central Nervous System Stimulants Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cathartics Gastrointestinal Agents |