Colonoscopy examination of intestine
Conditions
Interventions
In this study, half of the children (i.e. around 125) will receive the study
drug (Eziclen) and the other half will receive the comparator treatment
(Klean-Prep).
Eziclen is administered as a one-
Sponsors
Ipsen Pharmaceuticals
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints and Evaluations concerning efficacy: Non-inferiority of Eziclen versus Klean-Prep in the cleansing of the colon. This is determined by the blinded colonoscopist upon finalization of the scopy, by completion of a questionnaire (Cleansing Score) that is based on a 4-point scale (Poor, Fair, Good, Excellent cleaning). Only perfect bowel cleansing (graded as 4 or 3), which allow full, reliable examination of the mucosa, will be considered as successful. Primary efficacy will be assessed on the basis of preparation success or failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints and evaluations concerning efficacy: * Need to place a nasogastric tube to complete preparation; * Time to clear effluent (from first intake of preparation), as reported by the subject; * Need for rescue treatment (saline enema) because of inadequate preparation; * Cleansing Scores assessed by the 4-point scale (poor, fair, good, excellent); * Overall and segmental Cleansing Scores assessed by Boston Bowel Preparation Scale (BBPS); * Duration of intubation (from colonoscope introduction to caecal intubation); * Duration of examination, measured by colonoscope withdrawal time from caecum; * Procedures documented as completed (procedures that reached the caecum); * Treatment compliance: volumes ingested as measured by research staff; * Treatment acceptability, assessed by questionnaire completed by research staff or subject at the time of intake (unacceptable; badly but accepted; neither good nor bad; well accepted; very well accepted). Secondary endpoints and evaluations concerning safety and tolerability: * Collection of adverse events for up to 30 days following the day of colonoscopy: - Diagnosis or diagnostic findings made at colonoscopy will be reported as such and will not be reported as AEs unless the investigator observes mucosal lesions that he/she suspects to be related or possibly related to the colonic lavage. Such lesions will be biopsied. In this situation only, description of the colonoscopy findings and histological examination results will be reported as AEs. * Tolerability by a Symptom Scale after each dose of treatment. Subjects will rate their preparation related symptoms after intake (stomach cramping, stomach bloating and nausea) on a 5-point scale (ranging from no symptoms to severely distressing symptoms); * Description and histological examination of any colonic biopsy specimens of mucosal lesions suspected to have been caused by colonic lavage; * Vital signs including body weight and physical | — |
Countries
Netherlands
Outcome results
None listed