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

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ClinicalTrials.gov Identifier: NCT01649674
Recruitment Status : Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2011
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Boston Bowel Preparation Scale value [ Time Frame: at time of colonscopy ]
    evaluated by two endoscopists who are blinded to treatment assigned at randomization

  2. patient reported acceptability score [ Time Frame: just prior to colonscopy ]
    using visual analog scale


Secondary Outcome Measures :
  1. percent of bowel cleansing regimen dose assumed as reported by patient [ Time Frame: just prior to colonoscopy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649674


Locations
Italy
Presidio Ospedaliero Villa d'Agri
Marsicovetere, Italy
AO Fatebenefratelli ed Oftalmico
Milano, Italy
A.O.U. Seconda Universita di Napoli
Napoli, Italy
Clinica Mediterranea
Napoli, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Presidio Ospedaliero Ascalesi
Napoli, Italy
Presidio Ospedaliero Maresca
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

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01649674     History of Changes
Other Study ID Numbers: PRECOL2011-1
2011-000587-10 ( Registry Identifier: EudraCT )
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

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