A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, 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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522046-42-00

Acronym

NER1006-01/2025

Enrollment

218

Registered

2025-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic disease

Brief summary

Success rate of bowel cleansing (percentage of participants achieving adequate cleansing) based on BBPS.

Detailed description

Success rate of bowel cleansing (percentage of participants achieving successful cleansing) based on HCS., Participant compliance with treatment., Tolerability, palatability, and acceptability questionnaire using a Likert Scale.

Interventions

DRUGSODIUM PICOSULFATE

DRUGPLENVU Pulver zur Herstellung einer Losung zum Einnehmen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Success rate of bowel cleansing (percentage of participants achieving adequate cleansing) based on BBPS.	—

Secondary

Measure	Time frame
Success rate of bowel cleansing (percentage of participants achieving successful cleansing) based on HCS., Participant compliance with treatment., Tolerability, palatability, and acceptability questionnaire using a Likert Scale.	—

Countries

Belgium, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026