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

May 21, 2012 updated by: Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Como, Italy, 22100
        • Ospedale Valduce, Gastroenterologia
      • Milano, Italy, 20142
        • Ospedale S. Paolo
      • Milano, Italy, 20157
        • Ospedale L. Sacco, Endoscopic Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Moviprep, Norgine Ltd, Harefield, UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of bowel cleansing
Time Frame: Within 24 hrs
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
Within 24 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: In the 24 hours within assumption of study products
Occurrence of complications related to the intake or the two study products
In the 24 hours within assumption of study products
Tolerability
Time Frame: Within 12 hrs
Acceptability of the two study products in term of palatability and ease to take the products
Within 12 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Fatebenefratelli Sacco

Investigators

  • Principal Investigator: Gianpiero Manes, MD, Ospedale L. Sacco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2012

Last Update Submitted That Met QC Criteria

May 21, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low volume preparations

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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