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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.

Conditions
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Colon Cleansing for Colonoscopy

Intervention / Treatment
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* Drug: sodium picosulphate magnesium citrate
* Drug: low-volume PEG -ascorbic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium picosulphate/magnesium citrate<br> | Drug: sodium picosulphate magnesium citrate<br>* 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.<br>* Other names: Citrafleet, IBI Lorenzini, Aprilia, Italy;|
| Active Comparator: low-volume PEG -ascorbic acid<br> | Drug: low-volume PEG -ascorbic acid<br>* 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.<br>* Other names: Moviprep, Norgine Ltd, Harefield, UK;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon preparation, Colonoscopy, Polyethylene glycol, Sodium Picosulphate