Clinical trial 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)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 398
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


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.

Primary outcomes:
measure: Polyp detection rate
timeFrame: At colonoscopy
Secondary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: At the Colonoscopy
measure: ADR and PDR by location
timeFrame: at the colonoscopy
measure: Cancer detection rate
timeFrame: at the colonoscopy
measure: Flat lesion only detection rate
timeFrame: at the colonoscopy
measure: Advanced risk lesion detection rate
timeFrame: at the colonoscopy
measure: Colonoscopy completion rate
timeFrame: at the colonoscopy
measure: Colon cleansing quality
timeFrame: at the colonoscopy
measure: Acceptability and tolerability of medication using patient questionnaires
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
Study officials:
affiliation: Klinikum Aschaffenburg-Alzenau
name: Wolfgang Fishbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.