ClinicalTrials.Veeva

Menu

PMC Split Preparation for Colon Cleansing (MAGIC-P)

L

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems