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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Gianpiero Manes, MD, Ospedale L. Sacco - Polo Universitario
ClinicalTrials.gov Identifier:
NCT01603654
First received: May 17, 2012
Last updated: May 21, 2012
Last verified: May 2012

May 17, 2012
May 21, 2012
January 2011
June 2011   (final data collection date for primary outcome measure)
Efficacy of bowel cleansing [ Time Frame: Within 24 hrs ] [ Designated as safety issue: No ]
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
Same as current
Complete list of historical versions of study NCT01603654 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: In the 24 hours within assumption of study products ] [ Designated as safety issue: Yes ]
    Occurrence of complications related to the intake or the two study products
  • Tolerability [ Time Frame: Within 12 hrs ] [ Designated as safety issue: Yes ]
    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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01603654
Low volume preparations
No
Dr Gianpiero Manes, MD, Ospedale L. Sacco - Polo Universitario
Ospedale L. Sacco – Polo Universitario
Not Provided
Principal Investigator: Gianpiero Manes, MD Ospedale L. Sacco
Ospedale L. Sacco – Polo Universitario
May 2012

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