Comparison of Bowel Cleansing Regimens Prior to Colonoscopy (PRECOL2011-1)
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute, Naples
Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01649674
First received: July 23, 2012
Last updated: February 27, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Colonoscopy
Drug Information available for:
Sodium citrate
Magnesium citrate
Magnesium
Polyethylene
Sodium Picosulfate
U.S. FDA Resources
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: | March 2014 |
| Estimated Primary Completion Date: | July 2013 (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
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: | February 27, 2013 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Citric Acid Picosulfate sodium Magnesium citrate Anticoagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013