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

Colon Cleansing for Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603654
• Other study ID #: Low volume preparations
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2012
• Last updated: May 21, 2012
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: Ospedale L. Sacco – Polo Universitario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cleansing for Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Ospedale Valduce, Gastroenterologia	Como
Italy	Ospedale L. Sacco, Endoscopic Unit	Milano
Italy	Ospedale S. Paolo	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale L. Sacco – Polo Universitario

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of bowel cleansing	Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products	Within 24 hrs	No
Secondary	Safety	Occurrence of complications related to the intake or the two study products	In the 24 hours within assumption of study products	Yes
Secondary	Tolerability	Acceptability of the two study products in term of palatability and ease to take the products	Within 12 hrs	Yes