PMC Split Preparation for Colon Cleansing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

862 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Colon Cleansing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A: standard regimen

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.

Group Type ACTIVE_COMPARATOR

Sodium picosulphate/magnesium Citrate

Intervention Type DRUG

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

Group B

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.

Group Type ACTIVE_COMPARATOR

Sodium picosulphate/magnesium Citrate

Intervention Type DRUG

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

Interventions

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Sodium picosulphate/magnesium Citrate

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

Intervention Type DRUG

Other Intervention Names

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Citrafleet

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes