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)

NCT01689792 | Completed Phase 4

• 1 other identifier: NOR-01/2011 (PDR)
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Polyp detection rate

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

  At colonoscopy

Secondary Outcomes (8)

• Adenoma Detection Rate (ADR)

  At the Colonoscopy

• ADR and PDR by location

  at the colonoscopy

• Cancer detection rate

  at the colonoscopy

• Flat lesion only detection rate

  at the colonoscopy

• Advanced risk lesion detection rate

  at the colonoscopy

Study Arms (2)

CitraFleet

ACTIVE COMPARATOR

Administration of CitraFleet

Drug: CitraFleet

MOVIPREP

EXPERIMENTAL

Administration of MOVIPREP

Drug: MOVIPREP

Interventions

MOVIPREP DRUG

MOVIPREP

CitraFleet DRUG

CitraFleet

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Klinikum Aschaffenburg

Aschaffenburg, Am Hasenkopf 1, Germany

Location

Related Publications (1)

• 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.

  PMID: 25950434 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Wolfgang Fishbach, MD

  Klinikum Aschaffenburg-Alzenau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 21, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 31, 2015

Record last verified: 2013-12

Locations

DE (1)