Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01603654
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):
Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco

May 17, 2012
May 22, 2012
May 22, 2012
January 2011
June 2011   (Final data collection date for primary outcome measure)
Efficacy of bowel cleansing [ Time Frame: Within 24 hrs ]
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
Same as current
No Changes Posted
  • Safety [ Time Frame: In the 24 hours within assumption of study products ]
    Occurrence of complications related to the intake or the two study products
  • Tolerability [ Time Frame: Within 12 hrs ]
    Acceptability of the two study products in term of palatability and ease to take the products
Same as current
Not Provided
Not Provided
Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy
A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Colon Cleansing for Colonoscopy
  • Drug: sodium picosulphate magnesium citrate
    Use of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water.
    Other Name: Citrafleet, IBI Lorenzini, Aprilia, Italy
  • Drug: low-volume PEG -ascorbic acid
    THe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid.
    Other Name: Moviprep, Norgine Ltd, Harefield, UK
  • Experimental: sodium picosulphate/magnesium citrate
    Intervention: Drug: sodium picosulphate magnesium citrate
  • Active Comparator: low-volume PEG -ascorbic acid
    Intervention: Drug: low-volume PEG -ascorbic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult outpatients
  • aged 18-85 years
  • undergoing elective colonoscopy

Exclusion Criteria:

  • previous colon resection
  • ileus
  • intestinal obstruction
  • toxic megacolon
  • severe heart failure (New York Heart Association [NYHA] Class III or IV)
  • acute cardiovascular disease
  • uncontrolled arterial hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg)
  • severe liver failure or ascites
  • end-stage renal failure
  • phenylketonuria
  • glucose-6-phosphate dehydrogenase deficiency. Women were excluded from the study if they were pregnant, breastfeeding
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Low volume preparations
Not Provided
Not Provided
Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco
ASST Fatebenefratelli Sacco
Not Provided
Principal Investigator: Gianpiero Manes, MD Ospedale L. Sacco
ASST Fatebenefratelli Sacco
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP