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

Phase 1

• Conditions: The trial is about comparing the efficacy of Plenvu with Picoprep. Bothare 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.; MedDRA version: 27.0Level: LLTClassification code 10061839Term: Endoscopy large bowelSystem Organ Class: 10022891 - Investigations; MedDRA version: 21.1Level: PTClassification code 10066943Term: Bowel preparationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-006617-11-DK
• Lead Sponsor: Region Nordjylland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-15
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1-Ambulant colonoscopy
2-Older than18

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified