Clinical trial NCT03008460: Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digestive System Disease
Keywords: Bowel preparation
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 \>40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

  \*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

Primary outcomes:
measure: Percentage of Subjects With Successful Overall Colon Preparation, Assessed With the Cleansing Score (4-point Scale)
timeFrame: At Day 2 (colonoscopy visit)
Secondary outcomes:
measure: Mean Colon Cleansing Score (4-point Scale)
timeFrame: At Day 2 (colonoscopy visit)
measure: Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment
timeFrame: At Day 2 (colonoscopy visit)
measure: Percentage of Subjects With Need for Rescue Treatment
timeFrame: At Day 2 (colonoscopy visit, before colonoscopy)
measure: Percentage of Subjects With Need for Nasogastric Tube To Complete Preparation
timeFrame: At Day 1 (treatment visit)
measure: Percentage of Subjects With Colonoscopy Procedure Documented as Completed
timeFrame: At Day 2 (colonoscopy visit)
measure: Median Time to Caecal Intubation
timeFrame: From colonoscope introduction to caecal intubation, assessed on Day 2 (colonoscopy visit)
measure: Mean Duration of Examination
timeFrame: From caecum intubation to withdrawal of the colonoscope, assessed on Day 2 (colonoscopy visit)
measure: Mean Score for Overall Treatment Acceptability, Assessed Using Treatment Acceptability Questionnaire
timeFrame: At Day 1 (treatment visit)
measure: Mean Overall Treatment Compliance
timeFrame: At Day 1 (treatment visit)
measure: Mean Subject Tolerability Total Score, Assessed Using a Symptom Scale
timeFrame: At Day 1 (treatment visit)
Other outcomes:
measure: Median Time to Clear Effluent
timeFrame: From first intake of prescription to first clear watery stool, assessed on Day 1 (treatment visit) and Day 2 (colonoscopy visit)
measure: Mean Time Between Last Intake of Fluids and Start of Colonoscopy Procedure
timeFrame: From end of treatment administration to start of colonoscopy, assessed on Day 1 (treatment visit) and Day 2 (colonoscopy visit)
Locations:
city: Praha
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Amiens
country: France
facility: Université de Picardie Jules Verne
city: Bron
country: France
facility: Hôpital Femme Mère-Enfant
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Essen
country: Germany
facility: Uniklinikum Essen
city: Hamm
country: Germany
facility: Evang Krankenhaus Hamm
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
city: Ulm
country: Germany
facility: Klinikum Ulm
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal
city: Napoli
country: Italy
facility: ORN Santobono-Pausilipon Padiglione Santobono
city: Pescara
country: Italy
facility: Ospedale "Spirito Santo" U.D.C.
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea
city: Amsterdam
country: Netherlands
facility: AMC Emma kinderziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
city: Gdańsk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z.o.o
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 6 Śląskiego
city: Kraków
country: Poland
facility: Uniwersytecki Szpital Dziecięcy w Krakowie
city: Lublin
country: Poland
facility: Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Dziecięcy w Lublinie
city: Warszawa
country: Poland
facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"
city: Wrocław
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Łódź
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
Study officials:
affiliation: Ipsen Consumer Healthcare
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: