PMC Split Preparation for Colon Cleansing

NCT01909219 | Completed Phase 4 DMC

• 1 other identifier: PMC split
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Colon Cleansing

Keywords

preparation, cleansing, colon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patients' acceptance, tolerability and compliance to the cleansing regimen

  24 hrs

Study Arms (2)

Group A: standard regimen

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

Sodium picosulphate/magnesium Citrate DRUG

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

Also known as: Citrafleet

Group A: standard regimen; Group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luigi Sacco University Hospital: lead

Study Sites (2)

Luigi Sacco University Hospital

Milan, Milano, I-20157, Italy

Location

Luigi Sacco University Hospital

Milan, I-20157, Italy

Location

Related Publications (1)

• 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.

  PMID: 25019969 DERIVED

MeSH Terms

Interventions

picosulfate sodium; magnesium citrate

Study Officials

• Gianpiero Manes, MD

  Sacco Huniversity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

IT (2)