A trial to compare efficacy and tolerability of Plenvu® and Picoprep® as cleansing agents of the large bowel before colonoscopy (examination of the bowel with a fiberoptic device)

2024-518544-21-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 1 Sep 2022 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 400
Countries 1
Sites 1

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to colonoscopy. The patients to be examined are all referred to exclude colorectal cancer disease. The cleansing process is not directly related to treatment of these patients but have an effect on the visualisation of the mucosa of the bowel and thus the quality of the colonoscopy.

Aim of the study is to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu® with the well established bowel preparation Picoprep® as cleansing agents before colonoscopy. This is to test whether the low volume Polyethylin Glycol-electrolytes lavage solution preparation Plenvu® would have…

Key facts

Sponsor
Aalborg University Hospital
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Trial duration
1 Sep 2022 → ongoing
Decision date (initial)
2024-11-05
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
GCP enhed Aalborg

External identifiers

EU CT number
2024-518544-21-00
EudraCT number
2021-006617-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Aim of the study is to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu® with the well established bowel preparation Picoprep® as cleansing agents before colonoscopy. This is to test whether the low volume Polyethylin Glycol-electrolytes lavage solution preparation Plenvu® would have non-inferior efficacy on bowel preparation compared with Picosulfate based Picoprep® with a better effect on compliance and tolerability.

Secondary objectives 1

  1. To compare the tolerability of both agents

Conditions and MedDRA coding

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to colonoscopy. The patients to be examined are all referred to exclude colorectal cancer disease. The cleansing process is not directly related to treatment of these patients but have an effect on the visualisation of the mucosa of the bowel and thus the quality of the colonoscopy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Ambulant colonoscopy
  2. Older than18

Exclusion criteria 12

  1. Younger than 18
  2. Known with severe heart failure
  3. Known with severe renal failure (eGFR<30)*
  4. Known with colonic stenosis
  5. Pregnant or breastfeeding
  6. Acute colonoscopy
  7. Cancer screening program colonoscopy
  8. Mentally retarded
  9. Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
  10. Patients with Phenylketonuria
  11. Patients with Glucose-6-phosphate-dehydrogenase deficiency
  12. Patients with rectum and/or colon resections

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Efficacy of plenvu is not inferior to picoprep

Secondary endpoints 1

  1. Tolerability of plenvu is not inferior to picoprep

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Plenvu

PRD5559366 · Product

Active substance
Ascorbic Acid
Substance synonyms
VITAMIN C, ASCORBIC ACID (E 300), CEVITAMIC ACID, (2R)-2-[(1S)-1,2-DIHYDROXYETHYL]-4,5-DIHYDROXY-FURAN-3-ONE
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
1 U unit(s)
Max total dose
2 U unit(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
A06AD65 — MACROGOL, COMBINATIONS
Marketing authorisation
58682
MA holder
NORGINE B.V.
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Picoprep, pulver til oral opløsning

PRD450275 · Product

Active substance
Sodium Picosulfate
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL USE
Max daily dose
1 U unit(s)
Max total dose
2 U unit(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
A06AB58 — SODIUM PICOSULFATE, COMBINATIONS
Marketing authorisation
46212
MA holder
FERRING LÆGEMIDLER A/S
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aalborg University Hospital

14 Total trials 9 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
Aalborg University Hospital
Address
Hobrovej 18-22
City
Aalborg
Postcode
9000
Country
Denmark

Scientific contact point

Organisation
Aalborg University Hospital
Contact name
Hayder Alqaisi

Public contact point

Organisation
Aalborg University Hospital
Contact name
Hayder Alqaisi

Third parties 1

OrganisationCity, countryDuties
GCP-enheden ved Aalborg og Aarhus Universitetshospitaler
ORL-000002031
 Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 400 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Aalborg University Hospital
Gastrointestinal Surgery, Hobrovej 18-22, 9000, Aalborg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2022-09-01 2022-09-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protokol CTIS 2.4.4
Recruitment arrangements (for publication) Placeholder 1
Subject information and informed consent form (for publication) Deltagerinformation_V2 3 2 23092024 uden rettelse 2.3.2
Subject information and informed consent form (for publication) Informeret samtykke_V1_08122021 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder 1
Summary of Product Characteristics (SmPC) (for publication) Placeholder 1
Synopsis of the protocol (for publication) Resume af protokol 2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-15 Denmark Acceptable
2024-11-05
 2024-11-05
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-12-08 Acceptable
2024-11-05

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