Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05436054

A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy

Led by Aalborg University Hospital · Updated on 2024-11-19

400

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

A

Aalborg University Hospital

Lead Sponsor

R

Regionshospital Nordjylland

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.

CONDITIONS

Official Title

A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for ambulant colonoscopy
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Known severe heart failure
  • Known severe renal failure (eGFR <30)
  • Known colonic stenosis
  • Pregnant or breastfeeding
  • Acute colonoscopy
  • Colonoscopy as part of cancer screening program
  • Mentally retarded
  • Repeat colonoscopy after cancellation due to bad bowel preparation
  • Phenylketonuria
  • Glucose-6-phosphate-dehydrogenase deficiency
  • History of colon or rectum resection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Aalborg University hospital

Aalborg, North Jutland, Denmark, 9000

Actively Recruiting

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Research Team

H

Hayder Alqaisi

CONTACT

L

Lars Andersen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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