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Colon PolypPhase 4NCT03742232

Study Comparing the Bowel Cleansing Efficacy of PLENVU® Versus SELG-ESSE® Using a 2-Day Split Dosing Regimen.

A Phase 4 study testing PEG3350 and Macrogol 4000 in people with Colon Polyp and Colon Adenoma, run by Istituto Clinico Humanitas at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicentre randomized parallel group phase IV study comparing the bowel cleansing efficacy, safety and tolerability of PLENVU® (a 1 litre PEG Bowel Cleansing Solution) versus SELG-ESSE® (a 4 litre PEG Bowel Cleansing Solution) using a 2-Day Split Dosing Regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Polyp, Colon Adenoma, Colon Lesion
What is being tested?
PEG3350 and Macrogol 4000
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
5 sitesItaly
Study dates
31 Oct 2018to 31 Mar 2020
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

  • Patients must provide written informed consent.
  • Male and female outpatients and inpatients aged: ≥18 to ≤85 years undergoing a screening, surveillance or diagnostic colonoscopy.
  • Females of child-bearing potential must have a negative pregnancy test at Screening and at Visit 2 and must be practising one of the following methods of birth control and agree to continue with the regimen throughout the study period:
  • Oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom;
  • Intrauterine device in combination with a condom; Double barrier method (condom*, and occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/ cream/suppository); *A female condom and a male condom should not be used together as friction between the two can result in either product failing.
  • If any female patient has a positive pregnancy test at Visit 2, they will be excluded from further participation in the study for the efficacy evaluation, i.e. they will not undergo the colonoscopy procedure. The Investigator will be required to arrange a colonoscopy procedure outside of the study.
  • Note: The above birth control methods do not apply to females who are postmenopausal or surgically sterile i.e. 12 months of natural (spontaneous) amenorrhea or 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy, or whose sole sexual partner has had a vasectomy and has received medical assessment of the surgical success.
  • Willing, able and competent to complete the entire study and to comply with instructions.

Who cannot join

  • Patients with past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
  • Patients with ongoing severe acute Inflammatory Bowel Disease (IBD).
  • Patients who have had previous significant gastrointestinal surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
  • Regular use of laxatives or colon motility altering drugs (i.e. more than 2-3 times per week) in the last 28 days prior to the Screening Visit and/or laxative use within 72 hours prior to administration of the preparation.
  • Patients with active intestinal bleeding episodes
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Show all 23Show fewer
  • Known phenylketonuria.
  • Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not including sulfa-based products) or any other component of the investigational product or comparator.
  • Past history within the last 12 months or evidence of any on-going clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
  • History of uncontrolled hypertension with systolic blood pressure >170 mmHg and diastolic blood pressure >100 mmHg.
  • Patients with cardiac insufficiency NYHA grades III or IV.
  • Patients with severe renal insufficiency.
  • Patients with known liver disease of grades B and C according to the Child Pugh classification.
  • Patients suffering from dehydration at screening as evaluated by the Investigator from physical examination.
  • Patients with pre-existing clinically significant electrolyte abnormalities, or dehydration.
  • Patients with impaired consciousness that might predispose them to pulmonary aspiration.
  • Patients undergoing colonoscopy for foreign body removal and/or decompression.
  • Patients who are pregnant or lactating, or intending to become pregnant during the study.
  • Clinically relevant findings on physical examination based on the Investigator's judgment.
  • History of drug or alcohol abuse within the 12 months prior to dosing.
  • Concurrent participation in an investigational drug or device study or participation within three months of study entry.
  • Patients who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures, e.g. cognitively impaired, debilitated or fragile patients.
  • Patients who are ordered to live in an institution on court or authority order.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Centro di Riferimento Oncologico

    Aviano, Italia

  • Fondazione Poliambulanza

    Brescia, Italia

  • ISMETT

    Palermo

  • Nuovo Regina Margherita Hospital

    Roma, Italia

  • Humanitas Research Hospital

    Rozzano, 20089

Other trials in Italy

About this study

Official title: A Multicentre Randomized Parallel Group Phase IV Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of PLENVU® Versus SELG-ESSE® Using a 2-Day Split Dosing Regimen.

This study is a multicentre randomized parallel group phase IV study comparing the bowel cleansing efficacy, safety and tolerability of PLENVU® (a 1 litre PEG Bowel Cleansing Solution) versus SELG-ESSE® (a 4 litre PEG Bowel Cleansing Solution) using a 2-Day Split Dosing Regimen.

Being tested
PEG3350, Macrogol 4000
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG3350Drug

    PLENVU® supplied as two powder-for-oral-solution formulations. One formulation contains PEG3350, sodium sulphate and electrolytes, and the second formulation contains PEG3350, sodium ascorbate, ascorbic acid, and electrolytes.

    PLENVU® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).

  • Macrogol 4000Drug

    SELG-ESSE® supplied as powder-for-oral-solution containing PEG4000, simethicone, sodium sulphate and sodium bicarbonate, and electrolytes.

    SELG-ESSE® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).

Study groups in NCT03742232
Study groupRoleWhat they receive
PLENVUExperimentalPLENVU® supplied as two powder-for-oral-solution formulations. One formulation contains PEG3350, sodium sulphate and electrolytes, and the second formulation contains PEG3350, sodium ascorbate, ascorbic acid, and electrolytes.
Receives: Drug: PEG3350
SELG-ESSEActive comparatorSELG-ESSE® supplied as powder-for-oral-solution containing PEG4000, simethicone, sodium sulphate and sodium bicarbonate, and electrolytes.
Receives: Drug: Macrogol 4000

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel cleansing efficacy

    To evaluate the overall bowel cleansing efficacy of 2-day split-dosing with PLENVU compared to a 2-day split-dosing regimen with SELG-ESSE®, graded according to the Boston Bowel Preparation Scale (BBPS) in patients undergoing screening, surveillance or diagnostic colonoscopy.

    Measured: 1 Day of colonoscopy

Secondary outcomes (3)

  1. Polip Detection Rate

    To assess the overall Polip Detection Rate with PLENVU compared to SELG-ESSE

    Measured: 1 Day of colonoscopy

  2. Adenoma Detection Rate

    To assess the overall Adenoma Detection Rate with PLENVU compared to SELG-ESSE;

    Measured: 1 Day of colonoscopy

  3. Adverse events

    To assess the incidence of adverse events in PLENVU group comparing SELG-ESSE arm

    Measured: 4 days after colonscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start31 Oct 2018
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742232
Sponsor's protocol ID
2063
Status last verified
Aug 2020
First submitted
13 Nov 2018
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Repici A, Spada C, Cannizzaro R, Traina M, Maselli R, Maiero S, Galtieri A, Guarnieri G, Di Leo M, Lorenzetti R, Capogreco A, Spadaccini M, Antonelli G, Zullo A, Amata M, Ferrara E, Correale L, Granata A, Cesaro P, Radaelli F, Minelli Grazioli L, Anderloni A, Fugazza A, Finati E, Pellegatta G, Carrara S, Occhipinti P, Buda A, Fuccio L, Manno M, Hassan C. Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study. Gastrointest Endosc. 2021 Oct;94(4):823-831.e9. doi: 10.1016/j.gie.2021.04.020. Epub 2021 Apr 30.

    PubMed 33940043

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEG3350 and Macrogol 4000 in people with Colon Polyp and Colon Adenoma, run by Istituto Clinico Humanitas at 5 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 8 inclusion and 23 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

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?

Bowel cleansing efficacy (time frame: 1 Day of colonoscopy). 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 NCT03742232, 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 27 Aug 2020.

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