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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 19, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: May 1, 2024 to Dec 1, 2025
    • Study completion date: Aug 1, 2024 to Dec 1, 2025
    • Eligibility criteria expanded, about 6 words
    • Study site revised
    v4
  2. Primary completion date: May 1, 2023 to May 1, 2024
    • Study completion date: Aug 1, 2023 to Aug 1, 2024
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jan 2023 to May 1, 2023
    • Study completion date: Jan 2023 to Aug 1, 2023
    • Start date changed from estimate of Sep 1, 2022 to Oct 1, 2022
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05436054
Lead Sponsor Aalborg University Hospital
Collaborators: Regionshospital Nordjylland, Norgine
Conditions
(from sponsor)		 Colon Disease
Related terms Colonic Diseases
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov