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

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aalborg University Hospital
• Collaborators: Norgine; North Denmark Regional Hospital
• Treatments: Picosulfate sodium

Criteria

Inclusion Criteria:

• Ambulant colonoscopy

• Older than18

Exclusion Criteria:

• Younger than 18

• Known with severe heart failure

• Known with severe renal failure (eGFR<30)

• Known with colonic stenosis

• Pregnant or breastfeeding

• Acute colonoscopy

• Cancer screening program colonoscopy

• Mentally retarded

• Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.

• Patients with Phenylketonuria

• Patients with Glucose-6-phosphate-dehydrogenase deficiency