NCT01909219

PMC Split Preparation for Colon Cleansing

A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 862 (actual)
• Sponsor: Luigi Sacco University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy

Detailed description

Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy. Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if \>2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.

Conditions

• Colon Cleansing

Interventions

Type	Name	Description
DRUG	Sodium picosulphate/magnesium Citrate	Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2013-04-01
• First posted: 2013-07-26
• Last updated: 2013-07-26

Locations

2 sites across 1 country: Italy