NCT05436054 A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
| NCT ID | NCT05436054 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aalborg University Hospital |
| Condition | Colon Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2022-10-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 for 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 * Patients with colon or rectum resection
Contact & Investigator
Lars Andersen, Consultant
STUDY DIRECTOR
Region of North Jutland
Frequently Asked Questions
Who can join the NCT05436054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05436054 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05436054 currently recruiting?
Yes, NCT05436054 is actively recruiting participants. Contact the research team at haidermahmoud1991@gmail.com for enrollment information.
Where is the NCT05436054 trial being conducted?
This trial is being conducted at Aalborg, Denmark.
Who is sponsoring the NCT05436054 clinical trial?
NCT05436054 is sponsored by Aalborg University Hospital. The principal investigator is Lars Andersen, Consultant at Region of North Jutland. The trial plans to enroll 400 participants.