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NCT Number: NCT01689792

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)

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum Aschaffenburg

Aschaffenburg, Am Hasenkopf 1, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MoviPrep

Drug

CitraFleet

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Flat lesion only detection rate

    Time frame: at the colonoscopy

    Flat lesion only detection of the patients

  5. Advanced risk lesion detection rate

    Time frame: at the colonoscopy

    Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous

  6. Colonoscopy completion rate

    Time frame: at the colonoscopy

    The rate of colonoscopy completion

  7. Colon cleansing quality

    Time frame: at the colonoscopy

    Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©

  8. 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

Sponsors and collaborators

Lead sponsor

Norgine

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2012
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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