2025-522046-42-00招募中3 期
A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 9
- 主要终点
- Success rate of bowel cleansing (percentage of participants achieving adequate cleansing) based on BBPS.
研究概览
简要总结
To describe the success rate of bowel cleansing in paediatric participants (aged 1 to < 18 years) after administration of PLENVU® or sodium picosulfate as measured by the Boston Bowel Preparation Scale (BBPS).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant who is 1 to < 18 years of age at the Screening Visit.
- •A participant (or their legal guardian, if required by local regulations) must be able to accurately maintain the participant’s take-home record, including items of general health.
- •Participant who requires a colonoscopy.
- •Participants must weigh a minimum of 10 kg, and participants aged 1 to < 4 years of age must be above the 10th percentile of weight for age, according to the World Health Organization (WHO) Weight Charts (refer to Section 8.3.1 and Appendix 6, Section 10.6 of the Clinical Study Protocol), at the time of signing the informed consent.
- •Male and female (according to their reproductive organs and functions assigned by chromosomal complement).
- •Female participant of childbearing potential (CBP), i.e. who has experienced menarche or is ≥ 8 years of age and will be, or could possibly be, engaging in sexual activity during the course of the study (refer to Appendix 4, Section 10.4.1 of the Clinical Study Protocol for further details): • Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative [e.g. three ambiguous results]) within 24 hours before the first dose of study intervention. Refer to Section 8.3.6 of the Clinical Study Protocol for further details. • Must use a highly effective method of contraception (failure rate < 1% per year) from Day 1 and throughout the Safety Follow-up Period, as described in Appendix 4, Section 10.4 of the Clinical Study Protocol. The Investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention. • Must not be breastfeeding.
- •Male participants who are sexually active or who become sexually active during the study should use condoms from Day 1 and throughout the Safety Follow-up Period.
- •The Investigator, or a person designated by the Investigator, will obtain written informed consent and/or assent from each study participant (and their legal guardian, if required by local regulations; as defined in Appendix 1, Section 10.1.3 of the Clinical Study Protocol) before any study-specific activity is performed unless a waiver of informed consent has been granted by the Ethics Committee (EC). All legal guardians, if applicable, should be fully informed, and all participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.
- •Participant is able to receive regular external feeding (solid food; bottle, or cup feed) without breastfeeding.
- •If required by local regulations or deemed necessary by the Investigator, a legal guardian or primary caregiver must be available to help the CRU personnel ensure follow-up; accompany the participant to the CRU on each assessment day according to the SoA (e.g. able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant using the rating scales during the scheduled study visit.
排除标准
- •Participant has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution).
- •Participant has any laboratory values with the following deviations at the Screening Visit: a. Haemoglobin < 8 g/dL. b. Platelet count < 80000/μL.
- •Participant has clinically significant laboratory/urinalysis/haematological abnormalities (including coagulation profile, if available) at Screening that contraindicates undergoing bowel preparation and/or colonoscopy.
- •Participant has impaired consciousness that might predispose them to pulmonary aspiration.
- •Participant has experienced significant blood loss (10% of blood volume) without blood volume replacement or haemoglobin replacement by blood volume or other appropriate therapy, e.g. iron therapy, within 60 days prior to the start of the study.
- •Participant has a clinically significant cardiac rhythm or functional disorder.
- •Participant has a known clinically significant chromosome abnormality.
- •Participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension between birth and randomisation based on assessment of the Investigator.
- •Participant has renal insufficiency with glomerular filtration rate of < 90 mL/min/1.73m2).
- •Participant has any laboratory values with the following deviations at the Screening Visit: a. Serum albumin < 1.4 g/dL. b. International normalised ratio > 1.
- •Participant has regularly used laxatives or colon motility altering drugs in the last month (i.e. more than two times per week) and/or has used one or more laxatives within 72 hours prior to administration of the preparation.
- •Participant has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- •Participant has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.
- •Participant has taken monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce seizure threshold within one week of baseline procedures.
- •Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.
- •Participant has a significant neurological disorder or a past history of seizures (excluding simple febrile seizures), or is currently on medication lowering seizure threshold (e.g. tricyclic antidepressants), or has used seizure threshold lowering medication within 14 days prior to administration of the preparation.
- •Current enrolment OR past participation in another investigational study in which an investigational intervention (e.g. drug, vaccine, invasive device) was administered within 60 days before planned first dose of study intervention in this clinical study, as assessed by the Investigator.
- •Participant has baseline QTc (corrected by Bazett’s formula [QTcB] or Frederica’s formula [QTcF]) of greater than 460 msec, congenital prolonged QT syndrome, prolonged QTc secondary to diabetes mellitus or family history of prolonged QT syndrome.
- •Participant is pregnant, lactating, or intending to become pregnant during the study.
- •Participant has clinically relevant findings on physical examination based on the Investigator's judgement that contraindicates undergoing bowel preparation and/or colonoscopy.
- •Participant who is ≥ 8 years of age has history of drug, nicotine, or alcohol abuse within the 12 months prior to dosing or has a positive result in the drug/nicotine/alcohol test at Screening.
- •Significant history or family history that would preclude participation.
- •Participant has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- •Participant has history of sudden infant death in a sibling.
- •Any participant who, in the opinion of the Investigator, should not be included in the study for any reason; e.g. cognitively impaired, debilitated, fragile, or vulnerable.
- •Participant has history of significant GI surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmann's procedure and de- functioning ileostomy, or other similar surgeries involving structure and function of the small or large colon.
- •Participant has known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •Participant has known phenylketonuria.
- •Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
- •Participant has a history of uncontrolled hypertension according to the values specified in the 2016 European Society of Hypertension guidelines for the management of high blood pressure (BP) in children and adolescents, i.e. BP that is above the 95th percentile (1 to 15 years of age) or > 140/90 mmHg (16 to < 18 years of age; Appendix 7, Section 10.7 of the Clinical Study Protocol).
- •Participant has uncontrolled pre-existing electrolyte abnormalities based on screening laboratory results such as hypernatraemia, hyponatraemia, hyperphosphatemia,hypermagnesaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme inhibitors judged clinically significant by the Investigator.
结局指标
主要结局
Success rate of bowel cleansing (percentage of participants achieving adequate cleansing) based on BBPS.
Success rate of bowel cleansing (percentage of participants achieving adequate cleansing) based on BBPS.
次要结局
- Success rate of bowel cleansing (percentage of participants achieving successful cleansing) based on HCS.
- Participant compliance with treatment.
- Tolerability, palatability, and acceptability questionnaire using a Likert Scale.
研究者
Richard Ng
Scientific
Norgine Limited
研究点 (9)
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