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)

NCT ID: NCT01689792

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-12-31

Brief Summary

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

CitraFleet

Administration of CitraFleet

Group Type: ACTIVE_COMPARATOR

CitraFleet

Intervention Type: DRUG

MOVIPREP

Administration of MOVIPREP

Group Type: EXPERIMENTAL

MOVIPREP

Intervention Type: DRUG

Interventions

MOVIPREP

Intervention Type: DRUG

CitraFleet

Intervention Type: DRUG

Eligibility 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.

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Fishbach, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Aschaffenburg-Alzenau

Locations

Klinikum Aschaffenburg

Aschaffenburg, , Germany

Countries

Germany

References

Pohl J, Halphen M, Kloess HR, Fischbach W. Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study. PLoS One. 2015 May 7;10(5):e0126067. doi: 10.1371/journal.pone.0126067. eCollection 2015.

Reference Type: DERIVED

PMID: 25950434 (View on PubMed)

Other Identifiers

NOR-01/2011 (PDR)

Identifier Type: -

Identifier Source: org_study_id