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)
- Trial ID
- 2025-522046-42-00
- Protocol
- NER1006-01/2025
- Sponsor
- Norgine Limited
Trial statistics
Objectives
The primary objective of this study is to describe the success rate of **bowel cleansing** in **paediatric participants** aged 1 to less than 18 years following administration of PLENVU® or **sodium picosulfate**, as measured by the **Boston Bowel Preparation Scale (BBPS)**. This assessment is clinically relevant for evaluating the adequacy of bowel preparation prior to **colonoscopy** in the paediatric population, which is essential for ensuring optimal visualization of the colonic mucosa and diagnostic accuracy.
The secondary objectives are:
• To describe the success rate of bowel cleansing in paediatric participants aged 1 to less than 18 years after administration of PLENVU® or sodium picosulfate as measured by the **Harefield Cleansing Scale (HCS)**.
• To determine the **safety**, **tolerability**, **palatability**, and **acceptability** of PLENVU® as compared to sodium picosulfate in paediatric participants aged 1 to less than 18 years.
Participants
This clinical trial enrolled a total of **23 participants** aged **1 to less than 18 years** requiring **colonoscopy** for **colonic disease**. Both **male and female participants** were included in the study population. The trial involved a **vulnerable population** consisting of **pediatric patients**. Participants were required to weigh a minimum of **10 kg**, with those aged 1 to less than 4 years needing to be above the **10th percentile of weight for age** according to World Health Organization standards. All participants needed to be able to receive regular external feeding, including solid food, bottle, or cup feeding, without breastfeeding. **Female participants of childbearing potential** were required to use highly effective contraception and have negative pregnancy testing, while sexually active **male participants** were required to use condoms during the study period. Selection criteria ensured that participants or their legal guardians could accurately maintain take-home records and comply with scheduled visits and study procedures.
Plans and Procedures
This is a Phase 3, multicentre, randomised, parallel-group, active-controlled, central reader colonoscopist-blind clinical trial designed to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU compared to sodium picosulfate in paediatric participants aged 1 to less than 18 years who require colonoscopy. The study employs a 1:1 randomisation scheme, assigning participants to receive either the test product PLENVU, which contains ascorbic acid, sodium ascorbate, potassium chloride, sodium chloride, and macrogol 3350, or the comparator product sodium picosulfate. Both products are administered as oral solutions for bowel preparation. The trial is conducted in participants with colonic disease who are scheduled to undergo surveillance, therapeutic, or diagnostic colonoscopy.
The primary objective is to describe the success rate of bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS), which assesses the adequacy of bowel preparation. The primary endpoint is the percentage of participants achieving adequate cleansing based on BBPS scores. Secondary endpoints include the success rate of bowel cleansing using the Harrogate Cleansing Scale (HCS), participant compliance with treatment, and assessment of tolerability, palatability, and acceptability using a Likert Scale questionnaire. The study aims to provide comprehensive data on the effectiveness and acceptability of PLENVU in the paediatric population.
The maximum treatment period for both study products is 2 days, with a maximum daily dose of 1 dosage form and a maximum total dose of 2 dosage forms. Participants must weigh a minimum of 10 kg, and those aged 1 to less than 4 years must be above the 10th percentile of weight for age according to World Health Organization (WHO) Weight Charts. Female participants of childbearing potential must have a negative pregnancy test within 24 hours before the first dose and must use highly effective contraception throughout the study and Safety Follow-up Period. Male participants who are sexually active must use condoms from Day 1 throughout the Safety Follow-up Period.
The trial includes a Screening Visit where eligibility is assessed and informed consent or assent is obtained from participants and their legal guardians as required by local regulations. Participants must be able to receive regular external feeding without breastfeeding and must be able to maintain take-home records documenting general health information. If required by local regulations, a legal guardian or primary caregiver must be available to accompany the participant to the clinical research unit on each assessment day and provide information using rating scales during scheduled study visits. The study involves scheduled follow-up visits to assess efficacy and safety outcomes, with procedures outlined in the Schedule of Activities.
The estimated recruitment start date is 2 February 2026, and the estimated end date is 6 January 2027. Participant involvement extends from the Screening Visit through the treatment period, colonoscopy procedure, and Safety Follow-up Period. Conditions that may lead to early termination from the study include withdrawal of consent, protocol violations, safety concerns as determined by the Investigator, pregnancy in female participants, or administrative reasons. The study design ensures comprehensive evaluation of bowel cleansing efficacy and safety in the paediatric population while maintaining appropriate safeguards for participant welfare.
Treatment
The experimental medication in this clinical trial is **PLENVU**, administered as a **powder for oral solution**. PLENVU contains five active substances: **ascorbic acid**, **sodium ascorbate**, **potassium chloride**, **sodium chloride**, and **macrogol 3350**. The medication is administered via the **oral route**. The maximum daily dose is 1 dosage form, with a maximum total dose of 2 dosage forms over the treatment period. The maximum treatment period is 2 days. PLENVU will be used in the **paediatric population** in this trial, which represents an extension beyond its current marketing authorization.
The **comparator treatment** used in this study is **sodium picosulfate**, formulated as a **powder for oral solution in sachet**. Sodium picosulfate is administered via the **oral route**. The dosing regimen consists of a maximum daily dose of 1 dosage form, with a maximum total dose of 2 dosage forms. The maximum treatment period for sodium picosulfate is 2 days. This comparator serves as an **active-controlled** treatment arm in the randomized, parallel-group study design.
The study employs a **1:1 randomization** scheme, allocating participants equally between the PLENVU and sodium picosulfate treatment groups. Both investigational products are intended for **bowel cleansing** in preparation for **colonoscopy** in paediatric participants aged 1 to less than 18 years. The study design incorporates a **central reader colonoscopist-blind** assessment to evaluate bowel cleansing efficacy using the **Boston Bowel Preparation Scale (BBPS)**. Participant compliance and treatment administration will be monitored throughout the study period to ensure adherence to the prescribed dosing schedules.
Efficacy
The primary efficacy endpoint will be the success rate of **bowel cleansing**, defined as the percentage of participants achieving adequate cleansing, as measured by the **Boston Bowel Preparation Scale** (BBPS). Secondary efficacy endpoints will include the success rate of bowel cleansing based on the **Harefield Cleansing Scale** (HCS), defined as the percentage of participants achieving successful cleansing. Additional secondary endpoints will assess participant compliance with treatment and evaluate tolerability, palatability, and acceptability through a questionnaire utilizing a **Likert Scale**.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participant who is 1 to < 18 years of age at the Screening Visit.
- Participant who requires a colonoscopy.
- Participants must weigh a minimum of 10 kg, and participants aged 1 to < 4 years of age must be above the 10th percentile of weight for age, according to the World Health Organization (WHO) Weight Charts (refer to Section 8.3.1 and Appendix 6, Section 10.6 of the Clinical Study Protocol), at the time of signing the informed consent.
- Male and female (according to their reproductive organs and functions assigned by chromosomal complement).
- Female participant of childbearing potential (CBP), i.e. who has experienced menarche or is ≥ 8 years of age and will be, or could possibly be, engaging in sexual activity during the course of the study (refer to Appendix 4, Section 10.4.1 of the Clinical Study Protocol for further details): • Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative [e.g. three ambiguous results]) within 24 hours before the first dose of study intervention. Refer to Section 8.3.6 of the Clinical Study Protocol for further details. • Must use a highly effective method of contraception (failure rate < 1% per year) from Day 1 and throughout the Safety Follow-up Period, as described in Appendix 4, Section 10.4 of the Clinical Study Protocol. The Investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention. • Must not be breastfeeding.
- Male participants who are sexually active or who become sexually active during the study should use condoms from Day 1 and throughout the Safety Follow-up Period.
- The Investigator, or a person designated by the Investigator, will obtain written informed consent and/or assent from each study participant (and their legal guardian, if required by local regulations; as defined in Appendix 1, Section 10.1.3 of the Clinical Study Protocol) before any study-specific activity is performed unless a waiver of informed consent has been granted by the Ethics Committee (EC). All legal guardians, if applicable, should be fully informed, and all participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.
- Participant is able to receive regular external feeding (solid food; bottle, or cup feed) without breastfeeding.
- If required by local regulations or deemed necessary by the Investigator, a legal guardian or primary caregiver must be available to help the CRU personnel ensure follow-up; accompany the participant to the CRU on each assessment day according to the SoA (e.g. able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant using the rating scales during the scheduled study visit.
- A participant (or their legal guardian, if required by local regulations) must be able to accurately maintain the participant’s take-home record, including items of general health.
Exclusion Criteria
- Participant has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution).
- Participant has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- Participant has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- Participant has history of significant GI surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmann's procedure and de- functioning ileostomy, or other similar surgeries involving structure and function of the small or large colon.
- Participant has known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Participant has known phenylketonuria.
- Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
- Participant has a history of uncontrolled hypertension according to the values specified in the 2016 European Society of Hypertension guidelines for the management of high blood pressure (BP) in children and adolescents, i.e. BP that is above the 95th percentile (1 to 15 years of age) or > 140/90 mmHg (16 to < 18 years of age; Appendix 7, Section 10.7 of the Clinical Study Protocol).
- Participant has uncontrolled pre-existing electrolyte abnormalities based on screening laboratory results such as hypernatraemia, hyponatraemia, hyperphosphatemia,hypermagnesaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme inhibitors judged clinically significant by the Investigator.
- Participant has any laboratory values with the following deviations at the Screening Visit: a. Haemoglobin < 8 g/dL. b. Platelet count < 80000/μL.
- Participant has clinically significant laboratory/urinalysis/haematological abnormalities (including coagulation profile, if available) at Screening that contraindicates undergoing bowel preparation and/or colonoscopy.
- Participant has impaired consciousness that might predispose them to pulmonary aspiration.
- Participant has experienced significant blood loss (10% of blood volume) without blood volume replacement or haemoglobin replacement by blood volume or other appropriate therapy, e.g. iron therapy, within 60 days prior to the start of the study.
- Participant has a clinically significant cardiac rhythm or functional disorder.
- Participant has a known clinically significant chromosome abnormality.
- Participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension between birth and randomisation based on assessment of the Investigator.
- Participant has renal insufficiency with glomerular filtration rate of < 90 mL/min/1.73m2).
- Participant has any laboratory values with the following deviations at the Screening Visit: a. Serum albumin < 1.4 g/dL. b. International normalised ratio > 1.2.
- Participant has regularly used laxatives or colon motility altering drugs in the last month (i.e. more than two times per week) and/or has used one or more laxatives within 72 hours prior to administration of the preparation.
- Participant has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.
- Participant has taken monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce seizure threshold within one week of baseline procedures.
- Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.
- Participant has a significant neurological disorder or a past history of seizures (excluding simple febrile seizures), or is currently on medication lowering seizure threshold (e.g. tricyclic antidepressants), or has used seizure threshold lowering medication within 14 days prior to administration of the preparation.
- Current enrolment OR past participation in another investigational study in which an investigational intervention (e.g. drug, vaccine, invasive device) was administered within 60 days before planned first dose of study intervention in this clinical study, as assessed by the Investigator.
- Participant has baseline QTc (corrected by Bazett’s formula [QTcB] or Frederica’s formula [QTcF]) of greater than 460 msec, congenital prolonged QT syndrome, prolonged QTc secondary to diabetes mellitus or family history of prolonged QT syndrome.
- Participant is pregnant, lactating, or intending to become pregnant during the study.
- Participant has clinically relevant findings on physical examination based on the Investigator's judgement that contraindicates undergoing bowel preparation and/or colonoscopy.
- Participant who is ≥ 8 years of age has history of drug, nicotine, or alcohol abuse within the 12 months prior to dosing or has a positive result in the drug/nicotine/alcohol test at Screening.
- Significant history or family history that would preclude participation.
- Participant has history of sudden infant death in a sibling.
- Any participant who, in the opinion of the Investigator, should not be included in the study for any reason; e.g. cognitively impaired, debilitated, fragile, or vulnerable.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Recruiting | 02 Feb 2026 | 27 |
 Croatia | Not Yet Recruiting | 02 Feb 2026 | 14 |
 Germany | Recruiting | 02 Feb 2026 | 33 |
 Hungary | Recruiting | 02 Feb 2026 | 18 |
 Italy | Recruiting | 02 Feb 2026 | 39 |
 The Netherlands | Recruiting | 02 Feb 2026 | — |
 Poland | Recruiting | 02 Feb 2026 | 50 |
 Portugal | Not Yet Recruiting | 02 Feb 2026 | 17 |
 Spain | Recruiting | 02 Feb 2026 | 20 |
| Netherlands | — | — | 31 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
PLENVU Pulver zur Herstellung einer Losung zum Einnehmen | Test | PULVER ZUR HERSTELLUNG EINER LÖSUNG ZUM EINNEHMEN | ORAL | 1 | 2 | PRD5854215 |
SODIUM PICOSULFATE | Comparator | — | ORAL | 1 | 2 | SUB10569MIG |