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

NCT03742232 | Completed Phase 4 DMC

• 1 other identifier: 2063
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Colon Polyp; Colon Adenoma; Colon Lesion

Outcome Measures

Primary Outcomes (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.

  1 Day of colonoscopy

Secondary Outcomes (3)

• Polip Detection Rate

  1 Day of colonoscopy

• Adenoma Detection Rate

  1 Day of colonoscopy

• Adverse events

  4 days after colonscopy

Study Arms (2)

PLENVU

EXPERIMENTAL

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.

Drug: PEG3350

SELG-ESSE

ACTIVE COMPARATOR

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

Drug: Macrogol 4000

Interventions

PEG3350 DRUG

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).

PLENVU

Macrogol 4000 DRUG

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).

SELG-ESSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (5)

Centro di Riferimento Oncologico

Aviano, Italia, Italy

Location

Fondazione Poliambulanza

Brescia, Italia, Italy

Location

Nuovo Regina Margherita Hospital

Roma, Italia, Italy

Location

ISMETT

Palermo, Italy

Location

Humanitas Research Hospital

Rozzano, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 33940043 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

polyethylene glycol 3350; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: October 31, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)