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Digestive System DiseasePhase 3EASYKIDNCT03008460

Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy

A Phase 3 study testing Eziclen®/Izinova® and Klean-Prep® in people with Digestive System Disease, run by Ipsen at 24 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight… Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Digestive System Disease
What is being tested?
Eziclen®/Izinova® and Klean-Prep®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
24 sitesin 6 countries
Study dates
15 Oct 2017to 29 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Provision of signed informed consent form to participate in the study obtained from the adolescent's parent(s)/ legal representative and a signed assent form from the adolescent according to local law
  • Male or female subjects between 12 to 17 years of age (inclusive)
  • Body weight more than 40 kg
  • Female of childbearing potential must have a negative pregnancy test
  • If female, and of child-bearing potential, subject must use an acceptable form of birth control (hormonal birth control, intrauterine device (IUD), double-barrier method, or depot contraceptive)
  • Routinely accepted indication for undergoing colonoscopy, including but not limited to polyposis coli diagnosis or surveillance, gastrointestinal bleeding, unexplained diarrhoea or constipation, surveillance of inflammatory bowel disease or confirmation of mucosal healing, abdominal pain, abnormal endosonography or manometry, anaemia of unknown aetiology, cancer surveillance
  • In the investigator's judgment, the parent(s)/legal representative are/is mentally competent to provide informed consent for the subject to participate in the study
  • In the investigator's judgement, subject is able and willing to follow study procedures including drug administration and response to questionnaires

Who cannot join

  • Subject with known or suspected ileus, gastrointestinal obstruction, gastric retention (gastroparesis), rectal impaction, toxic colitis, severe ulcerative colitis or toxic megacolon, advanced carcinoma, swallowing disorders
  • Subject with known or suspected inflammatory bowel disease (Crohn's disease, ulcerative colitis) in moderate to severe active phase defined by Paediatric Crohn's Disease Activity Index (PCDAI) >30 or Paediatric Ulcerative Colitis Index (PUCAI) >34
  • Subject with bowel perforation or increased risk of bowel perforation, including connective tissue disorders or recent bowel surgery
  • Subject with previous significant gastrointestinal surgery (e.g. colostomy, colectomy, gastric bypass, stomach stapling)
  • Subject with uncontrolled pre-existing electrolyte abnormalities, or with electrolyte abnormalities based on Visit 1 laboratory results such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalaemia, hypocalcaemia, uncorrected dehydration, or secondary to the use of medications such as diuretics or angiotensin converting enzyme inhibitors judged clinically significant by the investigator
  • Subject with a prior history or current condition of severe renal (estimated glomerular filtration rate (GFR) less than 30 mL/min/1.73 m^2 as calculated by using the Schwartz bedside equation* [Schwartz et al, 2009]**), liver (ascites, Child-Pugh C), cardiac insufficiency (including congestive heart failure all grades) or hyperuricemia
Show all 20Show fewer
  • The estimated GFR will be calculated in patients with elevated creatinine at baseline
  • Schwartz GJ and Work DF. Measurement and Estimation of GFR in Children and Adolescents. Clin J Am Soc Nephrol. 2009; 4: 1832-1843
  • Female subject who is pregnant or lactating
  • Subject who has participated in another investigational drug treatment within the last 90 days before the first study visit
  • Subject with phenylketonuria
  • Subject with history of asthma or hypersensitivity to any ingredient of either drug product
  • Subject for whom intake of substances likely to affect gastrointestinal motility or urinary flow rate is required
  • Subject with requirement to take any other oral medication within 3 hours of starting the bowel preparation, as this may impact medication absorption
  • Subject with tendency for nausea and/or vomiting
  • Subject with impaired consciousness that predisposes them to pulmonary aspiration or who have known swallowing disorders
  • Subject with history of major medical/psychiatric conditions that, in the judgment of the investigator, would compromise safety in the study
  • Subject with mental or psychiatric condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
  • Subject with a condition that, in the opinion of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
  • Subject who has previous enrolment in this study or concomitant enrolment in other clinical studies

Trial locations and contacts

24 sites in 6 countries.

24 sites in 6 countries

Poland9 sites

  • Copernicus Podmiot Leczniczy Sp. z.o.o

    Gdansk, 80-803

  • Samodzielny Publiczny Szpital Kliniczny Nr 6 Śląskiego

    Katowice, 40-752

  • Uniwersytecki Szpital Dziecięcy w Krakowie

    Krakow, 30-663

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

    Lublin, 20-093

  • Uniwersytecki Szpital Dziecięcy w Lublinie

    Lublin, 20-093

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

    Wroclaw, 50-369

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Zabrze, 41-800

Other trials in Poland

Germany5 sites

  • Uniklinikum Essen

    Essen, 45147

  • Evang Krankenhaus Hamm

    Hamm, 59063

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103

  • Klinikum Ulm

    Ulm, 89075

  • HELIOS Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

France3 sites

  • Université de Picardie Jules Verne

    Amiens, 80054

  • Hôpital Femme Mère-Enfant

    Bron, 69677

  • Hôpital Necker Enfants Malades

    Paris, 75015

Other trials in France

Italy3 sites

  • ORN Santobono-Pausilipon Padiglione Santobono

    Naples, 680 122

  • Ospedale "Spirito Santo" U.D.C.

    Pescara, 65125

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, 00189

Other trials in Italy

Czechia2 sites

  • Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

  • Všeobecná fakultní nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Netherlands2 sites

  • AMC Emma kinderziekenhuis

    Amsterdam, 1105 AZ

  • Maasstad ziekenhuis

    Rotterdam, 3079 DZ

Other trials in Netherlands

About this study

Official title: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (Eziclen/Izinova®) in Paediatric Subjects Undergoing Colonoscopy: a Phase III, Multicentre, Randomised, Comparative Study Versus Klean-Prep® (PEG-Electrolytes), Administered on the Day Before Colonoscopy, Investigator-blinded, Non-inferiority in Adolescents of 12 to 17 Years of Age (Inclusive) >40 kg

The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.

Being tested
Eziclen®/Izinova®, Klean-Prep®
Keywords
Bowel preparation
Medical subject headings
Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eziclen®/Izinova®Drug

    Also called Suprep®

    Oral solution taken the evening before the colonoscopy

  • Klean-Prep®Drug

    Oral solution taken the evening before the colonoscopy

Study groups in NCT03008460
Study groupRoleWhat they receive
Eziclen®/Izinova®ExperimentalNot described
Receives: Drug: Eziclen®/Izinova®
Klean-Prep®Active comparatorNot described
Receives: Drug: Klean-Prep®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects With Successful Overall Colon Preparation, Assessed With the Cleansing Score (4-point Scale)

    Blinded overall assessment of preparation efficacy (Cleansing Score) was determined by the colonoscopist upon completion of the examination, based on a 4-point scale as follows:

    • 4 (Excellent) = No more than small bits of adherent faeces/fluid
    • 3 (Good) = Small amounts of faeces or fluid not interfering with examination
    • 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination
    • 1 (Poor) = Large amounts of faecal residue, additional cleansing required.

    Only perfect preparations graded as excellent (4) or good (3), which allowed full, reliable examination of the mucosa were considered as successful. The adjusted percentage of subjects with a successful preparation was determined using a logistic regression model, including treatment and country as covariates.

    Measured: At Day 2 (colonoscopy visit)

Secondary outcomes (10)

  1. Mean Colon Cleansing Score (4-point Scale)

    The Cleansing Score was determined by the blinded colonoscopist, based on a 4-point scale as follows:

    • 4 (Excellent) = No more than small bits of adherent faeces/fluid
    • 3 (Good) = Small amounts of faeces or fluid not interfering with examination
    • 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination
    • 1 (Poor) = Large amounts of faecal residue, additional cleansing required.

    The adjusted mean score was estimated using a 2-way analysis of variance (ANOVA), including treatment and country as covariates.

    Measured: At Day 2 (colonoscopy visit)

  2. Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment

    The BBPS score for each colon segment (left, transverse, right) was determined by the blinded colonoscopist as follows:

    • 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared
    • 1 = Portion of mucosa of the segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid
    • 2 = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well
    • 3 = Entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid.

    Each segment score ranged from 0-3. Global score was sum of the 3 segment scores and ranged from 0-9 (worst to best). Successful colon cleansing was defined as a global BBPS score ≥6. The adjusted mean score was estimated using a 2-way ANOVA, including treatment and country as covariates.

    Measured: At Day 2 (colonoscopy visit)

  3. Percentage of Subjects With Need for Rescue Treatment

    The percentage of subjects who needed rescue treatment (saline enema) prior to colonoscopy because of inadequate preparation intake was assessed.

    Measured: At Day 2 (colonoscopy visit, before colonoscopy)

  4. Percentage of Subjects With Need for Nasogastric Tube To Complete Preparation

    The percentage of subjects who needed placement of a nasogastric tube to achieve administration of the complete preparation was assessed.

    Measured: At Day 1 (treatment visit)

  5. Percentage of Subjects With Colonoscopy Procedure Documented as Completed

    The percentage of subjects with a complete colonoscopy, defined as a procedure that reached the caecum, was assessed.

    Measured: At Day 2 (colonoscopy visit)

  6. Median Time to Caecal Intubation

    The time to caecal intubation was defined as the time from colonoscope introduction to caecal intubation, estimated using the Kaplan-Meier product limit method. In the event the procedure did not reach the caecum, the subject was censored at time of withdrawal of colonoscope.

    Measured: From colonoscope introduction to caecal intubation, assessed on Day 2 (colonoscopy visit)

  7. Mean Duration of Examination

    The duration of examination for colonoscopy (in minutes) was measured by the difference between the time of caecum intubation and the time of withdrawal of the colonoscope. The adjusted mean duration of examination was estimated using a 2-way ANOVA, including treatment and country as covariates. Subjects for whom the caecum was not reached were excluded from the analysis.

    Measured: From caecum intubation to withdrawal of the colonoscope, assessed on Day 2 (colonoscopy visit)

  8. Mean Score for Overall Treatment Acceptability, Assessed Using Treatment Acceptability Questionnaire

    The Treatment Acceptability Questionnaire was completed by the caregiver or subject after the subject ended the intake of preparation. Subject acceptability was rated as follows:

    • 1 = Very badly accepted/unacceptable
    • 2 = Badly but accepted
    • 3 = Neither good nor bad
    • 4 = Well accepted
    • 5 = Very well accepted.

    Overall acceptability score is the average of scores from the 2 doses ranging from 1 - 5 (worst to best). The adjusted mean score was estimated using a 2-way ANOVA, including treatment and country as covariates.

    Measured: At Day 1 (treatment visit)

  9. Mean Overall Treatment Compliance

    Treatment compliance according the instructions of use provided in the prescription was assessed as the percentage of volume of fluid taken relative to the planned volume of fluid to be taken (measured by the caregiver and reported in the treatment questionnaire of subject's leaflet during treatment administration). Overall treatment compliance was derived from the total volumes of fluid (i.e. preparation + hydration for Eziclen®/Izinova® and preparation only for Klean-Prep®) and was assessed for dose 1, dose 2 and globally (accounting for both doses). The adjusted mean overall treatment compliance (%) was estimated using a 2-way ANOVA, including treatment and country as covariates.

    Measured: At Day 1 (treatment visit)

  10. Mean Subject Tolerability Total Score, Assessed Using a Symptom Scale

    Tolerability was assessed using a Symptom Scale after each dose of treatment for stomach cramping, stomach bloating and nausea on a paediatric 5-point scale as follows:

    • 1 = No symptom
    • 2 = Mild
    • 3 = Bothersome
    • 4 = Distressing
    • 5 = Severely distressing symptoms.

    The total tolerability score is the sum of the scores for the 3 symptoms ranging from 3 to 15 (best to worst). Mean total tolerability scores after dose 1 and dose 2 are presented.

    Measured: At Day 1 (treatment visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start15 Oct 2017
  3. Primary completion24 Feb 2020
  4. Study completion29 Jun 2020

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008460
Sponsor's protocol ID
F-FR-58800-003
Other IDs
2016-002265-60, 2016
Acronym
EASYKID
Status last verified
Mar 2021
First submitted
30 Dec 2016
Last updated
2 Mar 2021
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Socha P, Posovszky C, Szychta M, Viscogliosi F, Martemucci L, Grzybowska-Chlebowczyk U, Perrot V, Kornowski A, Benninga MA; EASYKID Study Group. Phase III Randomized Non-Inferiority Study of OSS Versus PEG + Electrolyte Colonoscopy Preparation in Adolescents. J Pediatr Gastroenterol Nutr. 2023 May 1;76(5):652-659. doi: 10.1097/MPG.0000000000003745. Epub 2023 Feb 22.

    PubMed 36821851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eziclen®/Izinova® and Klean-Prep® in people with Digestive System Disease, run by Ipsen at 24 sites in 6 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Poland, Germany, France, Italy, Czechia and 1 more country. 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?

Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Successful Overall Colon Preparation, Assessed With the Cleansing Score (4-point Scale) (time frame: At Day 2 (colonoscopy visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008460, which also lists 1 linked publication.

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 2 Mar 2021.

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