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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

Tracking Information
First Submitted Date  ICMJE May 17, 2012
First Posted Date  ICMJE May 22, 2012
Last Update Posted Date May 22, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
Efficacy of bowel cleansing [ Time Frame: Within 24 hrs ]
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy
Official Title  ICMJE A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colon Cleansing for Colonoscopy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2012)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01603654
Other Study ID Numbers  ICMJE Low volume preparations
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco
Study Sponsor  ICMJE ASST Fatebenefratelli Sacco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gianpiero Manes, MD Ospedale L. Sacco
PRS Account ASST Fatebenefratelli Sacco
Verification Date May 2012

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