Completed

NCT Number: NCT01603654

Sodium Picosulphate/Magnesium Citrate and 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.

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Key information

Conditions

Colon Cleansing for Colonoscopy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Valduce, Gastroenterologia, Como, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium picosulphate magnesium citrate

Drug

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

low-volume PEG -ascorbic acid

Drug

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

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Official study 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.

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 22, 2012
Registry last updated: May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.