CLARITY

• Research type

  Research Study

• Full title

  A Phase 3, multicentre, randomised (1:1), parallel-group, activecontrolled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)

• IRAS ID

  1012749

• Contact name

  Richard Ng

• Contact email

  RNg@norgine.com

• Sponsor organisation

  Norgine Limited

• Research summary

  The purpose of this study is to measure the bowel cleansing success rate of PLENVU® compared to sodium picosulfate in participants undergoing a colonoscopy. Investigators will use a special scale called the Boston Bowel Preparation Scale to measure this.
  The study will involve around 212 participants aged between 1 and 18 years old. The study duration will be up to 39 days with a treatment duration of two days involving one overnight stay in a clinical research unit.

  This study has the potential to advance medical care for children who need colonoscopies, by providing information on the use of PLENVU® in children. The findings could lead to improved patient experiences, more effective colonoscopy procedures, and ultimately, better health outcomes for paediatric patients requiring important diagnostic and therapeutic intervention.

  This study is being sponsored by Norgine Ltd.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  25/LO/0721

• Date of REC Opinion

  20 Oct 2025

• REC opinion

  Further Information Favourable Opinion