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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
History of Changes
  Purpose

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 Intervention Phase
Colon Cleansing for Colonoscopy
 Drug: sodium picosulphate magnesium citrate
Drug: low-volume PEG -ascorbic acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedale L. Sacco – Polo Universitario:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603654

Locations
Italy
Ospedale Valduce, Gastroenterologia
Como, Italy, 22100
Ospedale L. Sacco, Endoscopic Unit
Milano, Italy, 20157
Ospedale S. Paolo
Milano, Italy, 20142
Sponsors and Collaborators
Ospedale L. Sacco – Polo Universitario
Investigators
Principal Investigator: Gianpiero Manes, MD Ospedale L. Sacco
  More Information

No publications provided

Responsible Party: Dr Gianpiero Manes, MD, Principal investigator, Ospedale L. Sacco - Polo Universitario
ClinicalTrials.gov Identifier: NCT01603654     History of Changes
Other Study ID Numbers: Low volume preparations
Study First Received: May 17, 2012
Last Updated: May 21, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale L. Sacco – Polo Universitario:
Colon preparation
Colonoscopy
Polyethylene glycol
Sodium Picosulphate

Additional relevant MeSH terms:
Ascorbic Acid
Citric Acid
Picosulfate sodium
Magnesium citrate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
 Vitamins
Micronutrients
Growth Substances
Anticoagulants
Hematologic Agents
Therapeutic Uses
Chelating Agents
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013