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

Tracking Information

First Received Date ^ICMJE

May 17, 2012

Last Updated Date

May 21, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01603654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Arm (s)

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

Enrollment ^ICMJE

300

Completion Date

September 2011

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01603654

Other Study ID Numbers ^ICMJE

Low volume preparations

Has Data Monitoring Committee

Responsible Party

Dr Gianpiero Manes, MD, Ospedale L. Sacco - Polo Universitario

Study Sponsor ^ICMJE

Ospedale L. Sacco – Polo Universitario

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gianpiero Manes, MD

Ospedale L. Sacco

Information Provided By

Ospedale L. Sacco – Polo Universitario

Verification Date

May 2012

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

To Top