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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Investigator)
• Study Primary Completion Date: June 2011

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.

Arms, Groups and Cohorts

• Experimental: sodium picosulphate/magnesium citrate
• Active Comparator: low-volume PEG -ascorbic acid

Clinical Trial Outcome Measures

Primary Measures

• Efficacy of bowel cleansing
  • Time Frame: Within 24 hrs
  • Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products

Secondary Measures

• Safety
  • Time Frame: In the 24 hours within assumption of study products
  • Occurrence of complications related to the intake or the two study products
• Tolerability
  • Time Frame: Within 12 hrs
  • Acceptability of the two study products in term of palatability and ease to take the products

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • ASST Fatebenefratelli Sacco
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr Gianpiero Manes, MD, Principal investigator – ASST Fatebenefratelli Sacco
• Overall Official(s)
  • Gianpiero Manes, MD, Principal Investigator, Ospedale L. Sacco