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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.
 
ClinicalTrials.gov Identifier: NCT01603654
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Sponsor:
Information provided by (Responsible Party):
Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cleansing for Colonoscopy Drug: sodium picosulphate magnesium citrate Drug: low-volume PEG -ascorbic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
Study Start Date : January 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011


Arm Intervention/treatment
Experimental: sodium picosulphate/magnesium citrate 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

Active Comparator: low-volume PEG -ascorbic acid 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




Primary Outcome Measures :
  1. Efficacy of bowel cleansing [ Time Frame: Within 24 hrs ]
    Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products


Secondary Outcome Measures :
  1. Safety [ Time Frame: In the 24 hours within assumption of study products ]
    Occurrence of complications related to the intake or the two study products

  2. Tolerability [ Time Frame: Within 12 hrs ]
    Acceptability of the two study products in term of palatability and ease to take the products



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603654


Locations
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Italy
Ospedale Valduce, Gastroenterologia
Como, Italy, 22100
Ospedale S. Paolo
Milano, Italy, 20142
Ospedale L. Sacco, Endoscopic Unit
Milano, Italy, 20157
Sponsors and Collaborators
ASST Fatebenefratelli Sacco
Investigators
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Principal Investigator: Gianpiero Manes, MD Ospedale L. Sacco
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Responsible Party: Dr Gianpiero Manes, MD, Principal investigator, ASST Fatebenefratelli Sacco
ClinicalTrials.gov Identifier: NCT01603654    
Other Study ID Numbers: Low volume preparations
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012
Keywords provided by Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco:
Colon preparation
Colonoscopy
Polyethylene glycol
Sodium Picosulphate
Additional relevant MeSH terms:
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Ascorbic Acid
Picosulfate sodium
Magnesium citrate
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Cathartics
Gastrointestinal Agents