Back to resultsA 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)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
MOVIPREP
CitraFleet
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
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.
Sites / Locations
- Klinikum Aschaffenburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CitraFleet
MOVIPREP
Arm Description
Administration of CitraFleet
Administration of MOVIPREP
Outcomes
Primary Outcome Measures
Polyp detection rate
Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
Secondary Outcome Measures
Adenoma Detection Rate (ADR)
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
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
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
Flat lesion only detection of the patients
Advanced risk lesion detection rate
Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous
Colonoscopy completion rate
The rate of colonoscopy completion
Colon cleansing quality
Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©
Acceptability and tolerability of medication using patient questionnaires
The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01689792
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norgine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CitraFleet
Arm Type
Active Comparator
Arm Description
Administration of CitraFleet
Arm Title
MOVIPREP
Arm Type
Experimental
Arm Description
Administration of MOVIPREP
Intervention Type
Drug
Intervention Name(s)
MOVIPREP
Intervention Type
Drug
Intervention Name(s)
CitraFleet
Primary Outcome Measure Information:
Title
Polyp detection rate
Description
Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
Time Frame
At colonoscopy
Secondary Outcome Measure Information:
Title
Adenoma Detection Rate (ADR)
Description
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
Time Frame
At the Colonoscopy
Title
ADR and PDR by location
Description
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
Time Frame
at the colonoscopy
Title
Cancer detection rate
Description
Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population
Time Frame
at the colonoscopy
Title
Flat lesion only detection rate
Description
Flat lesion only detection of the patients
Time Frame
at the colonoscopy
Title
Advanced risk lesion detection rate
Description
Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous
Time Frame
at the colonoscopy
Title
Colonoscopy completion rate
Description
The rate of colonoscopy completion
Time Frame
at the colonoscopy
Title
Colon cleansing quality
Description
Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©
Time Frame
at the colonoscopy
Title
Acceptability and tolerability of medication using patient questionnaires
Description
The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Fishbach, MD
Organizational Affiliation
Klinikum Aschaffenburg-Alzenau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
Am Hasenkopf 1
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25950434
Citation
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.
Results Reference
derived
Learn more about this trial
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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