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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01603654

Enrollment

300

Registered

2012-05-22

Start date

2011-01-31

Completion date

2011-09-30

Last updated

2012-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cleansing for Colonoscopy

Keywords

Colon preparation, Colonoscopy, Polyethylene glycol, Sodium Picosulphate

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.

Interventions

DRUGsodium 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.

DRUGlow-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of bowel cleansing	Within 24 hrs	Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026