Comparison of Bowel Cleansing Regimens Prior to Colonoscopy (PRECOL2011-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01649674
First received: July 23, 2012
Last updated: January 3, 2014
Last verified: January 2014

July 23, 2012
January 3, 2014
November 2011
July 2014   (final data collection date for primary outcome measure)
  • Boston Bowel Preparation Scale value [ Time Frame: at time of colonscopy ] [ Designated as safety issue: No ]
    evaluated by two endoscopists who are blinded to treatment assigned at randomization
  • patient reported acceptability score [ Time Frame: just prior to colonscopy ] [ Designated as safety issue: No ]
    using visual analog scale
Same as current
Complete list of historical versions of study NCT01649674 on ClinicalTrials.gov Archive Site
percent of bowel cleansing regimen dose assumed as reported by patient [ Time Frame: just prior to colonoscopy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Bowel Cleansing Regimens Prior to Colonoscopy
PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Patients Undergoing Elective Colonoscopy
  • Drug: polyethylene glycole (PEG) solution
  • Drug: sodium picosulphate and magnesium citrate solution
  • Active Comparator: PEG
    polyethylene glycol solution 2 liters
    Intervention: Drug: polyethylene glycole (PEG) solution
  • Active Comparator: NapP
    Sodium picosulphate and magnesium citrate solution 300 ml
    Intervention: Drug: sodium picosulphate and magnesium citrate solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
525
December 2014
July 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Massimo Di Maio, M.D. +39 081 5903383 massimo.dimaio@usc-intnapoli.net
Italy
 
NCT01649674
PRECOL2011-1, 2011-000587-10
No
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Valentina D'Angelo, M.D. National Cancer Institute, Naples
Principal Investigator: Mario de Bellis, M.D. National Cancer Institute, Naples
National Cancer Institute, Naples
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP