PMC Split Preparation for Colon Cleansing (MAGIC-P)

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

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

Study Overview

• Status: Completed
• Conditions: Colon Cleansing
• Intervention / Treatment: Drug: Sodium picosulphate/magnesium Citrate

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.

• Study Type: Interventional
• Enrollment (Actual): 862
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, I-20157
    • Luigi Sacco University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult outpatients
• aged 18-85 yr
• undergoing elective colonoscopy

Exclusion Criteria:

• previous colon resection,
• ileus,
• intestinal obstruction,
• toxic megacolon,
• severe heart failure (NYHA Class III or IV),
• acute cardiovascular disease,
• uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg),
• severe liver cirrhosis (Child-Pugh score C),
• renal failure (creatinine clearance<30 mL/minute),
• ascites,
• phenylketonuria,
• glucose-6-phosphate dehydrogenase deficiency,
• pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: standard regimen; Patients in the group A (standard regimen) will be instructed to take the two sachets of sodium picosulphate/magnesium citrate diluted in a glass of water 2-4 hours apart, starting at 5 pm the day before colonoscopy.	Drug: Sodium picosulphate/magnesium Citrate; Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate; Other Names: Citrafleet
Active Comparator: Group B; Patients in the group B (split regimen) will be instructed to take the first sachet of sodium picosulphate/magnesium citrate at 7 pm the day before colonoscopy and the second one at 6 am in the morning on the day of colonoscopy.	Drug: Sodium picosulphate/magnesium Citrate; Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate; Other Names: Citrafleet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adequate colon cleansing	The primary endpoint of the study was the quality of overall colon cleansing, assessed by the endoscopist. Colon cleansing quality was dichotomized as "adequate" (score > 2 in each colon segment) or "inadequate" (score < 2 in one or more colon segments	24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' acceptance, tolerability and compliance to the cleansing regimen	The overall tolerance of the preparation and the severity of symptoms during the preparation period will be rated on a scale ranging from 0 (no discomfort) to 3 (severe discomfort). Patient acceptance of the preparation will be evaluated by a questionnaire with a 5-point scale ranging from 1 (worse) to 5 (best), assessing interference with daily activity, palatability, easiness in taking the product and the adjunctive clear fluid, and taste of product. Moreover, a nurse will ask the patient whether s/he have completed the prescribed regimen: compliance will be defined as poor for patients who consume less than 75% of product. Willingness to repeat the same preparation in the future will be also recorded.	24 hrs

Collaborators and Investigators

• Sponsor: Luigi Sacco University Hospital
• Investigators: Principal Investigator: Gianpiero Manes, MD, Sacco Huniversity Hospital

Publications and helpful links

General Publications

• Manes G, Repici A, Hassan C; MAGIC-P study group. Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy. Endoscopy. 2014 Aug;46(8):662-9. doi: 10.1055/s-0034-1365800. Epub 2014 Jul 14.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): July 26, 2013
• Last Update Submitted That Met QC Criteria: July 25, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: preparation, cleansing, colon
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Picosulfate sodium; Magnesium citrate
• Other Study ID Numbers: PMC split