Bowel Cleansing Prior to Clinical ProceduresPhase 3CLARITYNCT07218523
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
A Phase 3 study testing PLENVU® and Sodium picosulfate in people with Bowel Cleansing Prior to Clinical Procedures, run by Norgine at 46 sites in 10 countries.
Trial summary
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are scheduled to undergo a colonoscopy. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Bowel Cleansing Prior to Clinical Procedures
- What is being tested?
- PLENVU® and Sodium picosulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 46 sitesin 10 countries
- Study dates
- 29 Dec 2025to 6 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who require a colonoscopy.
- 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.
- 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.
- Must use a highly effective method of contraception (failure rate < 1% per year) from Day 1 and throughout the Safety Follow-up Period.
- Must not be breastfeeding.
- Participant is able to receive regular external feeding without breastfeeding.
Who cannot join
- 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).
- Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- Participant has history of significant GI surgeries.
- Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.
- Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
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- Has a history of uncontrolled hypertension.
- 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.
- Has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.
- Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.
- 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.
Trial locations and contacts
46 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 10 countries
Italy10 sites, 9 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Bergamo, 24127
- Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Firenze, 50139
- Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, Messina, 98124
- Recruiting
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milan, Milano, 20122
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale (AORN) Santobono Pausilipon
Naples, Napoli, 80129
- Recruiting
Azienda Ospedaliera Universitaria Federico II - Pediatria Generale
Naples, Napoli, 80131
- Recruiting
AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli - Pediatria
Naples, Napoli, 80138
- Recruiting
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, Roma, 00161
- Recruiting
Policlinico Gemelli - Endoscopia Digestiva Chirurgica
Roma, Roma, 00168
- Withdrawn
Azienda Ospedaliero-Universitaria Sant'Andrea - Pediatria
Roma, Roma, 00189
Poland6 sites, 5 recruiting
- Recruiting
Uniwersytecki Dzieciecy Szpital Kliniczny Imienia Ludwika Zamenhofa w Bialymstoku - Klinika Pediatrii, Gastroenterologii, Hepato
Bialystok, Podlaskie Voivodeship, 15-274
- Withdrawn
Gdanski Uniwersytet Medyczny (GUMed) - Katedra i Klinika Pediatrii, Gastroenterologii, Alergologii i Zywienia Dzieci
Gdansk, Pomeranian Voivodeship, 80-803
- Recruiting
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, 30-663
- Recruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu - Oddzial Pediatrii i Gastroenterologii
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
- Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka" - Oddzial Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii
Warsaw, Masovian Voivodeship, 04-730
- Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko SUM w Katowicach Oddzial Gastroenterologii i Hepatolog
Zabrze, Silesian Voivodeship, 41-800
United Kingdom6 sites, 6 recruiting
- Recruiting
Birmingham Women's and Children's NHS Foundation Trust - Birmingham Children's Hospital
Birmingham, B4 6NH
- Recruiting
NHS Lothian - Royal Hospital for Children & Young People
Edinburgh, Edinburgh, City of, EH16 4TJ
- Recruiting
King's College Hospital NHS Foundation Trust
London, York, SE5 9RS
- Recruiting
Barts Health NHS Trust
London, E1 1FR
- Recruiting
Great North Children's Hospital - Royal Victoria Infirmary
Newcastle upon Tyne, Newcastle Upon Tyne, NE1 4LP
- Recruiting
Sheffield Children's NHS Foundation Trust - Sheffield Children's Hospital
Sheffield, Sheffield, S10 2TH
Germany5 sites, 3 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 049006
- Withdrawn
Universitätsmedizin Der Johannes Gutenberg-Universität Mainz KöR
Mainz, Rhineland-Palatinate, 55131
- Recruiting
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
Münster, North Rhine-Westphalia, 48149
- Recruiting
Krankenhaus Barmherzige Brueder Regensburg - Klinik fuer Kinder- und Jugendmedizin
Regensburg, Bavaria, 93049
- Withdrawn
Helios Uniklinikum Wuppertal
Wuppertal, North Rhine-Westphalia, 42283
Spain5 sites, 5 recruiting
- Recruiting
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405
- Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009
- Recruiting
Hospital Materno Infantil de Málaga
Málaga, Málaga, 29011
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
- Recruiting
Parc Tauli Hospital Universitarli
Sabadell, Barcelona, 08208
Portugal4 sites, 4 recruiting
- Recruiting
Centro Clínico Académico(CCA) - Braga, Associação (2CA-Braga)
Braga, Braga District, 4710-243
- Not yet recruiting
Hospital Pediatrico da Unidad Local de Saude de Coimbra
Coimbra, Coimbra District, 3000-602
- Recruiting
Hospital da Luz S.A.
Lisbon, Lisbon District, 1500-650
- Recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, Porto District, 4050-011
Belgium3 sites, 3 recruiting
- Recruiting
Clinique CHC MontLegia
Alleur, Liege, 4000
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp, 2650
- Recruiting
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
Jette, Brussels Capital, 1090
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem Gyermekgyogyaszati Klinika Bokay Utcai Reszleg
Budapest, Budapest, 1083
- Recruiting
Heim Pal Orszagos Gyermekgyogyaszati Intezet
Budapest, Budapest, 1089
- Recruiting
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, Miskolc, 3526
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC - Pediatrics
Amsterdam, North Holland, 1105 AZ
- Recruiting
Amphia Hospital - Pediatrics
Breda, North Brabant, 4818 CK
- Recruiting
Isala Klinieken
Zwolle, Overijssel, 8025 AB
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Centre Rijeka
Rijeka, Primorje-Gorski Kotar County, 51000
About this study
Official title: 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)
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are scheduled to undergo a colonoscopy. Colonoscopy is a crucial procedure that helps to diagnose and manage various gastrointestinal (GI) conditions in paediatric patients. An adequate level of bowel preparation and cleansing is essential for effective colonoscopy to allow proper visualisation of the bowel.
Read the detailed description
This is a multicentre, active-controlled study in which the participants will be randomised 1:1 into one of two treatment groups - PLENVU® or sodium picosulfate in a 2-day split dosing regimen. The study will include -
- A Screening Period of up to 28 days (Day -28 to Day -1).
- A Treatment Period (Day 1 to Day 2) - Participants will be randomised to receive either PLENVU® or sodium picosulfate. Participants will be admitted into the Clinical Research Unit (CRU) on Day 1 and will remain in the CRU for the duration of study intervention administration (Day 1 and Day 2) and colonoscopy (Day 2). Participants will be discharged on Day 2 following the colonoscopy and evaluation of colon cleansing.
- A safety follow-up call or CRU visit (Day 9 ± 2 days).
- Being tested
- PLENVU®, Sodium picosulfate
- Keywords
- Colonoscopy, Paediatric, Harefield Cleansing Scale, Boston Bowel Preparation Scale, Plenvu, Polyethylene Glycol (PEG), Bowel Cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLENVU®Drug
Also called NER1006
PLENVU® will be administered as an oral solution.
Sodium picosulfateDrug
Also called PICOPREP®, PICOLAX®
Sodium picosulfate will be administered as an oral solution.
| Study group | Role | What they receive |
|---|---|---|
| PLENVU® | Experimental | Participants will receive PLENVU® in a 2-day split dosing regimen. Receives: Drug: PLENVU® |
| Sodium picosulfate | Active comparator | Participants will receive sodium picosulfate in a 2-day split dosing regimen according to the local label. Receives: Drug: Sodium picosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS)
To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the BBPS. The BBPS is a scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 3, evaluating the three colonic segments (i.e. right colon, transverse colon, and left colon) where a score of 0 indicates an unprepared colon segment with mucosa not visible due to solid stool, and 3 indicates mucosa of colon segment seen well, with bowel cleansing success defined as a score of ≥2 in all three segments.
Measured: Day 2
Secondary outcomes (3)
Percentage of participants achieving successful bowel cleansing based on Harefield Cleansing Scale (HCS)
To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the HCS. The HCS is scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 4 evaluating five segments (i.e. ascending colon, transverse colon, descending colon, sigmoid colon and rectum). The scores of the five segments will be the basis for a final grading of A, B, C, or D. Success is defined as a HCS grade of A or B.
Measured: Day 2
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
To determine the safety of PLENVU® as compared to sodium picosulfate in paediatric participants.
Measured: From Screening (Day -28 to Day -1) to safety follow-up (Day 9 ± 2 days)
Number of participants with a response on the Likert Scale
To determine the tolerability, palatability and acceptability of PLENVU® as compared to sodium picosulfate. A paediatric 5-point Likert Scale will be used to assess the tolerability, palatability and acceptability. It uses a combination of facial expressions and simple language to make it easier for children to understand and respond.
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start29 Dec 2025
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Cleansing Prior to Clinical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218523
- Sponsor's protocol ID
- NER1006-01/2025
- Other IDs
- 2025-522046-42-00, 2025
- Acronym
- CLARITY
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07218523
- Acronym / sponsor ID
- CLARITY / NER1006-01/2025
- Keywords
- Colonoscopy, Paediatric, Harefield Cleansing Scale, Boston Bowel Preparation Scale, Plenvu, Polyethylene Glycol (PEG), Bowel Cleansing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are scheduled to undergo a colonoscopy. Colonoscopy is a crucial procedure that helps to diagnose and manage various gastrointestinal (GI) conditions in paediatric patients. An adequate level of bowel preparation and cleansing is essential for effective colonoscopy to allow proper visualisation of the bowel.
Detailed description
This is a multicentre, active-controlled study in which the participants will be randomised 1:1 into one of two treatment groups - PLENVU® or sodium picosulfate in a 2-day split dosing regimen. The study will include -
- A Screening Period of up to 28 days (Day -28 to Day -1).
- A Treatment Period (Day 1 to Day 2) - Participants will be randomised to receive either PLENVU® or sodium picosulfate. Participants will be admitted into the Clinical Research Unit (CRU) on Day 1 and will remain in the CRU for the duration of study intervention administration (Day 1 and Day 2) and colonoscopy (Day 2). Participants will be discharged on Day 2 following the colonoscopy and evaluation of colon cleansing.
- A safety follow-up call or CRU visit (Day 9 ± 2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLENVU® | Experimental | Drug: PLENVU®Participants will receive PLENVU® in a 2-day split dosing regimen. |
| Sodium picosulfate | Active comparator | Drug: Sodium picosulfateParticipants will receive sodium picosulfate in a 2-day split dosing regimen according to the local label. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants who require a colonoscopy.
- 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.
- 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.
- Must use a highly effective method of contraception (failure rate < 1% per year) from Day 1 and throughout the Safety Follow-up Period.
- Must not be breastfeeding.
Key exclusion criteria (11 listed)
- 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).
- Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- Participant has history of significant GI surgeries.
- Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLENVU®Also: NER1006PLENVU® will be administered as an oral solution. | Drug | PLENVU® |
| Sodium picosulfateAlso: PICOPREP®, PICOLAX®Sodium picosulfate will be administered as an oral solution. | Drug | Sodium picosulfate |
Primary outcome
Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS)
Time frame: Day 2
To describe the success rate of bowel cleansing in paediatric participants after administration of PLENVU® or sodium picosulfate as measured by the BBPS. The BBPS is a scoring system used to assess bowel cleanliness during colonoscopy. The scale ranges from 0 to 3, evaluating the three colonic segments (i.e. right colon, transverse colon, and left colon) where a score of 0 indicates an unprepared colon segment with mucosa not visible due to solid stool, and 3 indicates mucosa of colon segment seen well, with bowel cleansing success defined as a score of ≥2 in all three segments.
3 secondary outcomes
Percentage of participants achieving successful bowel cleansing based on Harefield Cleansing Scale (HCS)
Time frame: Day 2
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
Time frame: From Screening (Day -28 to Day -1) to safety follow-up (Day 9 ± 2 days)
Number of participants with a response on the Likert Scale
Time frame: Day 1 and Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
46 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PLENVU® and Sodium picosulfate in people with Bowel Cleansing Prior to Clinical Procedures, run by Norgine at 46 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Italy, Poland, United Kingdom, Germany, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annabel Rigg (+441895453624, ARigg@norgine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving adequate bowel cleansing based on Boston Bowel Preparation Scale (BBPS) (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.