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

Sponsor

ASST Fatebenefratelli Sacco (Other)

Overall Status

Completed

CT.gov ID

NCT01603654

Collaborator

(none)

300

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cleansing for Colonoscopy	Drug: sodium picosulphate magnesium citrate Drug: low-volume PEG -ascorbic acid	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Efficacy of bowel cleansing [Within 24 hrs]
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products

Secondary Outcome Measures

Safety [In the 24 hours within assumption of study products]
Occurrence of complications related to the intake or the two study products
Tolerability [Within 12 hrs]
Acceptability of the two study products in term of palatability and ease to take the products

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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