Patients Undergoing Elective ColonoscopyPhase 4PRECOL2011-1NCT01649674
Comparison of Bowel Cleansing Regimens Prior to Colonoscopy
A Phase 4 study testing polyethylene glycole (PEG) solution and sodium picosulphate and magnesium citrate solution in people with Patients Undergoing Elective Colonoscopy, run by National Cancer Institute, Naples at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Elective Colonoscopy
- What is being tested?
- polyethylene glycole (PEG) solution and sodium picosulphate and magnesium citrate solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 7 sitesItaly
- Study dates
- Nov 2011to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy
- Informed consent
- Age > 18 years
Who cannot join
- Previous colonic resection
- Severe inflammatory bowel disease (IBD)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Presidio Ospedaliero Villa d'Agri
Marsicovetere
AO Fatebenefratelli ed Oftalmico
Milan
A.O.U. Seconda Universita di Napoli
Naples
Clinica Mediterranea
Naples
Istituto Nazionale dei Tumori
Naples
Presidio Ospedaliero Ascalesi
Naples
Presidio Ospedaliero Maresca
Torre del Greco
About this study
Official title: 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.
- Conditions
- Patients Undergoing Elective Colonoscopy
- Being tested
- polyethylene glycole (PEG) solution, sodium picosulphate and magnesium citrate solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycole (PEG) solutionDrug
sodium picosulphate and magnesium citrate solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| PEG | Active comparator | polyethylene glycol solution 2 liters Receives: Drug: polyethylene glycole (PEG) solution |
| NapP | Active comparator | Sodium picosulphate and magnesium citrate solution 300 ml Receives: Drug: sodium picosulphate and magnesium citrate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale value
evaluated by two endoscopists who are blinded to treatment assigned at randomization
Measured: at time of colonscopy
patient reported acceptability score
using visual analog scale
Measured: just prior to colonscopy
Secondary outcomes (1)
percent of bowel cleansing regimen dose assumed as reported by patient
Measured: just prior to colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Elective ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina D'Angelo, M.D., Principal investigator, National Cancer Institute, NaplesMario de Bellis, M.D., Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649674
- Sponsor's protocol ID
- PRECOL2011-1
- Other IDs
- 2011-000587-10
- Acronym
- PRECOL2011-1
- Status last verified
- Mar 2023
- First submitted
- 23 Jul 2012
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Angelo V, Piccirillo MC, Di Maio M, Gallo C, Bucci C, Civiletti C, Di Girolamo E, Marone P, Rossi GB, Tempesta AM, Tracey MC, Romano M, Miranda A, Taranto D, Sessa G, Esposito P, Salerno R, Pumpo R, De Filippo FR, Della Valle E, de Bellis M, Perrone F. A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial. Front Med (Lausanne). 2022 Dec 8;9:1013804. doi: 10.3389/fmed.2022.1013804. eCollection 2022.
PubMed 36569131
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.
- ClinicalTrials.gov ID
- NCT01649674
- Acronym / sponsor ID
- PRECOL2011-1 / PRECOL2011-1
- Conditions
- Patients Undergoing Elective Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG | Active comparator | Drug: polyethylene glycole (PEG) solutionpolyethylene glycol solution 2 liters |
| NapP | Active comparator | Drug: sodium picosulphate and magnesium citrate solutionSodium picosulphate and magnesium citrate solution 300 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy
- Informed consent
- Age > 18 years
Key exclusion criteria (2 listed)
- Previous colonic resection
- Severe inflammatory bowel disease (IBD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethylene glycole (PEG) solution | Drug | PEG |
| sodium picosulphate and magnesium citrate solution | Drug | NapP |
Primary outcome
Boston Bowel Preparation Scale value
Time frame: at time of colonscopy
evaluated by two endoscopists who are blinded to treatment assigned at randomization
patient reported acceptability score
Time frame: just prior to colonscopy
using visual analog scale
1 secondary outcome
percent of bowel cleansing regimen dose assumed as reported by patient
Time frame: just prior to colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 36569131D'Angelo V, Piccirillo MC, Di Maio M, Gallo C, Bucci C, Civiletti C, Di Girolamo E, Marone P, Rossi GB, Tempesta AM, Tracey MC, Romano M, Miranda A, Taranto D, Sessa G, Esposito P, Salerno R, Pumpo R, De Filippo FR, Della Valle E, de Bellis M, Perrone F. A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial. Front Med (Lausanne). 2022 Dec 8;9:1013804. doi: 10.3389/fmed.2022.1013804. eCollection 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina D'Angelo, M.D. principal investigator
National Cancer Institute, Naples
Mario de Bellis, M.D. principal investigator
National Cancer Institute, Naples
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polyethylene glycole (PEG) solution and sodium picosulphate and magnesium citrate solution in people with Patients Undergoing Elective Colonoscopy, run by National Cancer Institute, Naples at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale value (time frame: at time of colonscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01649674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.