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

NCT01603654 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-05-22

No results posted yet for this study

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.

Conditions

  • Colon Cleansing for Colonoscopy

Interventions

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.

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.

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Gianpiero Manes, MD · Ospedale L. Sacco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603654 on ClinicalTrials.gov