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This study is a multicentre randomized parallel group phase IV study comparing the bowel cleansing efficacy, safety and tolerability of PLENVUĀ® (a 1 litre PEG Bowel Cleansing Solution) versus SELG-ESSEĀ® (a 4 litre PEG Bowel Cleansing Solution) using a 2-Day Split Dosing Regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLENVU | Experimental | PLENVUĀ® 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. |
|
| SELG-ESSE | Active Comparator | SELG-ESSEĀ® supplied as powder-for-oral-solution containing PEG4000, simethicone, sodium sulphate and sodium bicarbonate, and electrolytes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG3350 | Drug | PLENVUĀ® 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. PLENVUĀ® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy). |
| Measure | Description | Time Frame |
|---|---|---|
| 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-ESSEĀ®, graded according to the Boston Bowel Preparation Scale (BBPS) in patients undergoing screening, surveillance or diagnostic colonoscopy. | 1 Day of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Polip Detection Rate | To assess the overall Polip Detection Rate with PLENVU compared to SELG-ESSE | 1 Day of colonoscopy |
| Adenoma Detection Rate | To assess the overall Adenoma Detection Rate with PLENVU compared to SELG-ESSE; |
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Inclusion Criteria:
Patients must provide written informed consent.
Male and female outpatients and inpatients aged: ā„18 to ā¤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:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Riferimento Oncologico | Aviano | Italia | Italy | |||
| Fondazione Poliambulanza |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33940043 | Derived | 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. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Macrogol 4000 | Drug | SELG-ESSEĀ® supplied as powder-for-oral-solution containing PEG4000, simethicone, sodium sulphate and sodium bicarbonate, and electrolytes. SELG-ESSEĀ® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy). |
|
| 1 Day of colonoscopy |
| Adverse events | To assess the incidence of adverse events in PLENVU group comparing SELG-ESSE arm | 4 days after colonscopy |
| Brescia |
| Italia |
| Italy |
| Nuovo Regina Margherita Hospital | Roma | Italia | Italy |
| ISMETT | Palermo | Italy |
| Humanitas Research Hospital | Rozzano | 20089 | Italy |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |