NL-OMON49151已完成3 期
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> - EASYKID
Ipsen Pharmaceuticals0 个研究点目标入组 65 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •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
排除标准
- •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
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