Colon CancerNCT05174845
Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia
An observational study of Colon Cancer and Colon Disease, run by Norgine at 12 sites in 2 countries.
Trial summary
A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Disease, Colon Cleansing
- What is being tested?
- 1L PEG + ASCORBIC ACID
- How many people
- 13,393 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Oct 2021to 1 Mar 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006
Who may be able to join
- Male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021
- Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day.
Who cannot join
- History of colorectal cancer o colectomy before the first colonoscopy
- Impossibility to obtain the required mandatory data
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Spain10 sites
Hospital San Rafael
A Coruña
HM Sant Jordi
Barcelona
Hospital del Mar
Barcelona
Hospital Doctor López Cano
Cadiz
Complejo hospitalario Ruber Juan Bravo
Madrid
Hospital Clinico San Carlos
Madrid
Hospital La Zarzuela
Madrid
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona
Hospital Quirón salud Sagrado Corazón
Seville
Consorcio Hospitalario Provincial de Castelló
Valencia
Portugal2 sites
Hospital da Senhora da Oliveira
Guimarães
Hospital CUF Descobertas
Lisbon
About this study
Official title: An Observational, Retrospective and Multicenter Study to Evaluate the Effectiveness and Safety of 1L (PEG)+ Ascorbic Acid Given for Bowel Preparation Prior to Colonoscopy in Iberia
A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.
Read the detailed description
Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data).
The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.
- Conditions
- Colon Cancer, Colon Disease, Colon Cleansing
- Being tested
- 1L PEG + ASCORBIC ACID
- Medical subject headings
- Colonic Neoplasms, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1L PEG + ASCORBIC ACIDDrug
Also called PLENVU, NER1006, PLEINVUE
- 2-Day Split-Dosing: The patient has taken the product in the evening before the scheduled colonoscopy and mandatory additional clear fluid. The patient has taken the second dose with mandatory additional clear fluids on the morning of the colonoscopy.
- Same Day: The patient has taken the first dose of the product on the day of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break, the patient has taken a second dose plus additional clear mandatory fluid.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients With Successful Bowel Cleansing (Overall Colon)
The proportion of patients with adequate total colon cleansing is defined as a Boston Bowel preparation scale (BBPS) score ≥ 2 in all segments (BBPS> 6).
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3.
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary outcomes (13)
Polyps Detection Rate in the total colon and in the right colon
Proportion of colonoscopies where at least one polyp was found and removed in total and right colon
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Adenoma Detection Rate in the total colon and in the right colon
Proportion of colonoscopies where at least one adenoma is found based on histological analysis in total and right colon
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Cecal intubation rate
Defined as the visualization of the ileocecal valve and / or appendicular orifice
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Cecal intubation time
Defined as the time required for the introduction of the colonoscope to reach the base of the cecum.
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Withdrawal time
Defined as the minutes spent inspecting the colon wall.
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Tolerability of the preparation, if available
Defined as good, fair or poor.
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Tolerability of the preparation, if available
Defined with a semi-quantitative scale of 1-5 (1 = totally agree, 2 = agree, 3 = Neutral, 4 = disagree, 5 = totally disagree)
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Adherence to the preparation, if available.
Percentage of patients with adherence to the preparation, defined as ingestion of at least 75% of each of the two doses
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Treatment satisfaction, if available
Percentage of patients satisfied with the preparation
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline
Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Safety of the preparation
Safety from registered adverse effects.
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Sub-analyzes will be conducted in different patient populations
Patients ≥ 65 years, patients with chronic constipation, with diabetes mellitus, with hypertension, with mild to moderate renal failure and with inflammatory bowel disease.
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Sub-analyzes of the primary and secondary outcomes
Sub-analyzes will be carried out by country, by the reason for the colonoscopy and by the recommended dietary regimen
Measured: Up to 2 days (from day of first dosing to day of colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xolomon Tree S.L.
- Responsible party
- Sponsor
- Investigators
- Jose Miguel Esteban López-Jamar, MD, Principal investigator, Norgine Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174845
- Sponsor's protocol ID
- PLEN-01/2021
- Status last verified
- May 2022
- First submitted
- 14 Dec 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Retrospective and Multicenter Study to Evaluate the Effectiveness and Safety of 1L (PEG)+ Ascorbic Acid Given for Bowel Preparation Prior to Colonoscopy in Iberia
- ClinicalTrials.gov ID
- NCT05174845
- Acronym / sponsor ID
- PLEN-01/2021
- Conditions
- Colon Cancer, Colon Disease, Colon Cleansing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,393 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Collaborators
- Xolomon Tree S.L.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 3 Jan 2022 (actual)
- 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.
A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.
Detailed description
Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data).
The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006
Key inclusion criteria (2 listed)
- Male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021
- Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day.
Key exclusion criteria (2 listed)
- History of colorectal cancer o colectomy before the first colonoscopy
- Impossibility to obtain the required mandatory data
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 |
|---|---|---|
| 1L PEG + ASCORBIC ACIDAlso: PLENVU, NER1006, PLEINVUE* 2-Day Split-Dosing: The patient has taken the product in the evening before the scheduled colonoscopy and mandatory additional clear fluid. The patient has taken the second dose with mandatory additional clear fluids on the morning of the colonoscopy. * Same Day: The patient has taken the first dose of the product on the day of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break, the patient has taken a second dose plus additional clear mandatory fluid. | Drug | – |
Primary outcome
Number of patients With Successful Bowel Cleansing (Overall Colon)
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
The proportion of patients with adequate total colon cleansing is defined as a Boston Bowel preparation scale (BBPS) score ≥ 2 in all segments (BBPS> 6).
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3.
13 secondary outcomes
Polyps Detection Rate in the total colon and in the right colon
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Adenoma Detection Rate in the total colon and in the right colon
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Cecal intubation rate
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Cecal intubation time
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Withdrawal time
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Tolerability of the preparation, if available
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Tolerability of the preparation, if available
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Adherence to the preparation, if available.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Treatment satisfaction, if available
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Safety of the preparation
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Sub-analyzes will be conducted in different patient populations
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Sub-analyzes of the primary and secondary outcomes
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Jose Miguel Esteban López-Jamar, MD principal investigator
Norgine Spain
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colon Disease, run by Norgine at 12 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Portugal. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients With Successful Bowel Cleansing (Overall Colon) (time frame: Up to 2 days (from day of first dosing to day of colonoscopy)). 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?
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 31 May 2022.