Overview

This trial is active, not recruiting.

Condition patients undergoing elective colonoscopy
Treatments polyethylene glycole (peg) solution, sodium picosulphate and magnesium citrate solution
Phase phase 4
Sponsor National Cancer Institute, Naples
Start date November 2011
End date July 2016
Trial size 525 participants
Trial identifier NCT01649674, 2011-000587-10, PRECOL2011-1

Summary

The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
polyethylene glycol solution 2 liters
polyethylene glycole (peg) solution
(Active Comparator)
Sodium picosulphate and magnesium citrate solution 300 ml
sodium picosulphate and magnesium citrate solution

Primary Outcomes

Measure
Boston Bowel Preparation Scale value
time frame: at time of colonscopy
patient reported acceptability score
time frame: just prior to colonscopy

Secondary Outcomes

Measure
percent of bowel cleansing regimen dose assumed as reported by patient
time frame: just prior to colonoscopy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: • Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy - Informed consent - Age > 18 years Exclusion Criteria: - Previous colonic resection - Severe inflammatory bowel disease (IBD)

Additional Information

Official title PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.
Principal investigator Valentina D'Angelo, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.