PMC Split Preparation for Colon Cleansing

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

Completed

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Key information

Conditions

Colon Cleansing

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luigi Sacco University Hospital, Milan, Milano, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium picosulphate/magnesium Citrate

Drug

Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate

Other names: Citrafleet

Primary outcomes

Rate of adequate colon cleansing

Time frame: 24 hrs

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

Secondary outcomes

Patients' acceptance, tolerability and compliance to the cleansing regimen

Time frame: 24 hrs

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.

Sponsors and collaborators

Lead sponsor

Luigi Sacco University Hospital

Other

Registry information

Official study title

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

Acronym: MAGIC-P

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Jul 26, 2013
Registry last updated: Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed