Clinical trial • Phase IV • Gastroenterology

ascorbic acid; sodium ascorbate; potassium chloride; sodium chloride; macrogol 3350 for Bowel preparation for colonoscopy

Phase IV trial of ascorbic acid; sodium ascorbate; potassium chloride; sodium chloride; macrogol 3350 for Bowel preparation for colonoscopy.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Bowel preparation for colonoscopy
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
05-11-2024

Trial design

Randomised, picoprep (comparator) — dose and schedule not specified in provided documents; comparator is an oral bowel cleansing solution.-controlled Phase IV trial across 1 site in Denmark.

Randomised
Yes
Comparator
Picoprep (comparator) — dose and schedule not specified in provided documents; comparator is an oral bowel cleansing solution.
Target Sample Size
400

Eligibility

Recruits 400 Vulnerable population not selected. The criteria explicitly exclude 'Mentally retarded'. Subject information and informed consent documents are provided (documents listed in CTIS: 'Deltagerinformation_V2 3 2 23092024 uden rettelse' and 'Informeret samtykke_V1_08122021'). Participants provide informed consent themselves; no paediatric assent procedures are indicated because minors are excluded..

Pregnancy Exclusion
Pregnant or breastfeeding
Vulnerable Population
Vulnerable population not selected. The criteria explicitly exclude 'Mentally retarded'. Subject information and informed consent documents are provided (documents listed in CTIS: 'Deltagerinformation_V2 3 2 23092024 uden rettelse' and 'Informeret samtykke_V1_08122021'). Participants provide informed consent themselves; no paediatric assent procedures are indicated because minors are excluded.

Inclusion criteria

  • {"criterion_text":"-Ambulant colonoscopy"}
  • {"criterion_text":"-Older than18"}

Exclusion criteria

  • {"criterion_text":"-Younger than 18"}
  • {"criterion_text":"-Patients with Phenylketonuria"}
  • {"criterion_text":"-Patients with Glucose-6-phosphate-dehydrogenase deficiency"}
  • {"criterion_text":"-Patients with rectum and/or colon resections"}
  • {"criterion_text":"-Known with severe heart failure"}
  • {"criterion_text":"-Known with severe renal failure (eGFR<30)*"}
  • {"criterion_text":"-Known with colonic stenosis"}
  • {"criterion_text":"-Pregnant or breastfeeding"}
  • {"criterion_text":"-Acute colonoscopy"}
  • {"criterion_text":"-Cancer screening program colonoscopy"}
  • {"criterion_text":"-Mentally retarded"}
  • {"criterion_text":"-Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Efficacy of plenvu is not inferior to picoprep","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-Tolerability of plenvu is not inferior to picoprep","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
400
Recruitment Window Months
63
Consent Approach
Informed consent forms and subject information documents are provided (documents in CTIS: 'Deltagerinformation_V2 3 2 23092024 uden rettelse' and 'Informeret samtykke_V1_08122021'). Participants (adults) provide consent themselves. No assent procedures for minors are indicated (minors are excluded).

Geography

Total Number Of Sites
1
Total Number Of Participants
400

Denmark

Earliest CTIS Part Ii Submission Date
27-10-2024
Latest Decision Or Authorization Date
05-11-2024
Processing Time Days
9
Number Of Sites
1
Number Of Participants
400

Sites

Site Name
Aalborg University Hospital
Department Name
Gastrointestinal Surgery
Principal Investigator Name
Ole Thorlacius-Ussing
Principal Investigator Email
otu@rn.dk
Contact Person Name
Ole Thorlacius-Ussing
Contact Person Email
otu@rn.dk

Sponsor

Primary sponsor

Full Name
Aalborg University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP-enheden ved Aalborg og Aarhus Universitetshospitaler","duties_or_roles":"Sponsor duties (listed in CTIS thirdParties; sponsorDuties code: 1)","organisation_type":"Health care"}

Investigational products

Investigational Product Name
Plenvu
Active Substance
ascorbic acid; sodium ascorbate; potassium chloride; sodium chloride; macrogol 3350
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 58682)
Maximum Dose
2 U unit(s)
Investigational Product Name
Picoprep, pulver til oral opløsning
Active Substance
sodium picosulfate; magnesium oxide, light; citric acid
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 46212)
Maximum Dose
2 U unit(s)

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