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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
Sponsor:
Information provided by (Responsible Party):
Norgine

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: MOVIPREP Drug: CitraFleet Phase 4

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CitraFleet
Administration of CitraFleet
Drug: CitraFleet
Experimental: MOVIPREP
Administration of MOVIPREP
Drug: MOVIPREP



Primary Outcome Measures :
  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 Outcome Measures :
  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



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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
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.

Information from the National Library of Medicine

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


Locations
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Germany
Klinikum Aschaffenburg
Aschaffenburg, Germany, Am Hasenkopf 1
Sponsors and Collaborators
Norgine
Investigators
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Principal Investigator: Wolfgang Fishbach, MD Klinikum Aschaffenburg-Alzenau

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Additional relevant MeSH terms:
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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