PMC Split Preparation for Colon Cleansing (MAGIC-P)

Luigi Sacco University Hospital

Status and phase: Completed; Phase 4

Conditions: Colon Cleansing

Treatments: Drug: Sodium picosulphate/magnesium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01909219

PMC split

Details and patient eligibility

About

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

Full 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.

Enrollment: 862 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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862 participants in 2 patient groups

Group A: standard regimen

Active Comparator group

Description:

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.

Treatment:

Drug: Sodium picosulphate/magnesium Citrate

Group B

Active Comparator group

Description:

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.

Treatment:

Drug: Sodium picosulphate/magnesium Citrate