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

NCT ID: NCT01603654

Last Updated: 2012-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

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.

Detailed Description

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Conditions

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Colon Cleansing for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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sodium picosulphate/magnesium citrate

Group Type EXPERIMENTAL

sodium picosulphate magnesium citrate

Intervention Type 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.

low-volume PEG -ascorbic acid

Group Type ACTIVE_COMPARATOR

low-volume PEG -ascorbic acid

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Citrafleet, IBI Lorenzini, Aprilia, Italy Moviprep, Norgine Ltd, Harefield, UK

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Fatebenefratelli Sacco

OTHER

Sponsor Role lead

Responsible Party

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Dr Gianpiero Manes, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianpiero Manes, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale L. Sacco

Locations

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Ospedale Valduce, Gastroenterologia

Como, , Italy

Site Status

Ospedale S. Paolo

Milan, , Italy

Site Status

Ospedale L. Sacco, Endoscopic Unit

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Low volume preparations

Identifier Type: -

Identifier Source: org_study_id

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