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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)


Phase 4
40 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Outcome Measure:

Polyp detection rate

Outcome Description:

Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist

Outcome Time Frame:

At colonoscopy

Safety Issue:

No

Principal Investigator

Wolfgang Fishbach, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum Aschaffenburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NOR-01/2011 (PDR)

NCT ID:

NCT01689792

Start Date:

November 2011

Completion Date:

June 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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