PMC Split Preparation for Colon Cleansing

Colon Cleansing Clinical Trial

— MAGIC-P  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909219
• Other study ID #: PMC split
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2013
• Last updated: July 25, 2013
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Luigi Sacco University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: April 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cleansing

Intervention

Drug:
• Sodium picosulphate/magnesium Citrate
Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate

Locations

Country	Name	City	State
Italy	Luigi Sacco University Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes