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

Phase 4

Completed

• Conditions: Colon Cleansing for Colonoscopy
• Interventions: Drug: sodium picosulphate magnesium citrate; Drug: low-volume PEG -ascorbic acid

• Registration Number: NCT01603654
• Lead Sponsor: ASST Fatebenefratelli Sacco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Status Verified: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-22
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium picosulphate/magnesium citrate	sodium picosulphate magnesium citrate	-
low-volume PEG -ascorbic acid	low-volume PEG -ascorbic acid	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Ospedale Valduce, Gastroenterologia; 🇮🇹 Como, Italy

Ospedale S. Paolo; 🇮🇹 Milano, Italy

Ospedale L. Sacco, Endoscopic Unit; 🇮🇹 Milano, Italy