Efficacy, safety and tolerability of a bowel cleansing preparation (Eziclen®/Izinova®)<br>in paediatric subjects undergoing colonoscopy: a Phase III, multicentre, randomised, comparative study versus Klean-Prep® (PEG-Electrolytes), administered on the day before colonoscopy,<br>Investigator-blinded, non-inferiority in adolescents of 12 to 17 years of age (inclusive) > 40 kg.<br>
- Conditions
- Colonoscopyexamination of intestine10017998
- Registration Number
- NL-OMON49151
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Subject MUST satisfy all of the following entry criteria before being allowed
to participate in the study:
(1) Provision of signed informed consent form (ICF) 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
(2) Male or female subjects between 12 to 17 years of age (inclusive)
(3) Body weight more than 40 kg
(4) Female of childbearing potential must have a negative pregnancy test
(5) 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)
(6) 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
(7) 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
(8) In the investigator*s judgement, subject is able and willing to follow
study procedures including drug administration and response to questionnaires
If any of the following apply, the subject MUST NOT enter/continue in the study:
(1) 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
(2) Subject with known or suspected inflammatory bowel disease (Crohn*s
disease, ulcerative colitis) in moderate to severe active phase defined by
PCDAI >30 (Crohn*s disease) or PUCAI >34 (ulcerative colitis)
(3) Subject with bowel perforation or increased risk of bowel perforation,
including connective tissue disorders or recent bowel surgery
(4) Subject with previous significant gastrointestinal surgery (e.g. colostomy,
colectomy, gastric bypass, stomach stapling)
(5) 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 (ACE) inhibitors judged clinically
significant by the investigator
(6) Subject with a prior history or current condition of severe renal
(estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 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
(7) Female subject who is pregnant or lactating
(8) Subject who has participated in another investigational drug treatment
within the last 90 days before the first study visit
(9) Subject with phenylketonuria
(10) Subject with history of asthma or hypersensitivity to any ingredient of
either drug product
(11) Subject for whom intake of substances likely to affect gastrointestinal
motility or urinary flow rate is required
(12) Subject with requirement to take any other oral medication within 3 hours
of starting the bowel preparation, as this may impact medication absorption
(13) Subject with tendency for nausea and/or vomiting
(14) Subject with impaired consciousness that predisposes them to pulmonary
aspiration or who have known swallowing disorders
(15) Subject with history of major medical/psychiatric conditions that, in the
judgment of the investigator, would compromise safety in the study
(16) 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
(17) 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
(18) Subject who has previous enrolment in this study or concomitant enrolment
in other clinical studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints and Evaluations concerning efficacy:<br /><br>Non-inferiority of Eziclen versus Klean-Prep in the cleansing of the colon.<br /><br>This is determined by the blinded colonoscopist upon finalization of the scopy,<br /><br>by completion of a questionnaire (Cleansing Score) that is based on a 4-point<br /><br>scale (Poor, Fair, Good, Excellent cleaning).<br /><br><br /><br>Only perfect bowel cleansing (graded as 4 or 3), which allow full, reliable<br /><br>examination of the mucosa, will be considered as successful.<br /><br>Primary efficacy will be assessed on the basis of preparation success or<br /><br>failure.</p><br>
- Secondary Outcome Measures
Name Time Method