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
  Purpose

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.


Condition Intervention Phase
Patients Undergoing Elective Colonoscopy
Drug: polyethylene glycole (PEG) solution
Drug: sodium picosulphate and magnesium citrate solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • percent of bowel cleansing regimen dose assumed as reported by patient [ Time Frame: just prior to colonoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 525
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEG
polyethylene glycol solution 2 liters
Drug: polyethylene glycole (PEG) solution
Active Comparator: NapP
Sodium picosulphate and magnesium citrate solution 300 ml
Drug: sodium picosulphate and magnesium citrate solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649674

Contacts
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

Locations
Italy
Presidio Ospedaliero Villa d'Agri Recruiting
Marsicovetere, Italy
AO Fatebenefratelli ed Oftalmico Recruiting
Milano, Italy
Istituto Nazionale dei Tumori Recruiting
Napoli, Italy
Clinica Mediterranea Recruiting
Napoli, Italy
A.O.U. Seconda Universita di Napoli Recruiting
Napoli, Italy
Presidio Ospedaliero Ascalesi Recruiting
Napoli, Italy
Presidio Ospedaliero Maresca Recruiting
Torre del Greco, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Valentina D'Angelo, M.D. National Cancer Institute, Naples
Principal Investigator: Mario de Bellis, M.D. National Cancer Institute, Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01649674     History of Changes
Other Study ID Numbers: PRECOL2011-1, 2011-000587-10
Study First Received: July 23, 2012
Last Updated: January 3, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Citric Acid
Pharmaceutical Solutions
Picosulfate sodium
Magnesium citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014