2023-504232-18-00已完成1 期
A Phase I, Single-Centre, Double-Blind, Randomized, Placebo-Controlled Clinical Trial To Determine Urinary Xylose Cut-Off Point For The Diagnosis Of Hypolactasia, After A Single Dose Of Gaxilose in Children Between 5 – 11 Years Of Age.
Venter Pharma S.L.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年6月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- PK analysis for urinary xylose excretion will be based on the following parameters: maximum urinary excretion rate detected at 0-3, 3-4 and 4-5h; its mean time during the corresponding interval (Tmax) and total xylose excreted (Ae0-5). All urine samples will be analyzed at a laboratory located in Hospital Universitario de Getafe
研究概览
简要总结
To establish a urinary cut-off point of xylose after a single dose of Gaxilose (LacTEST 0,45g) in healthy subjects between 5 - 11 years of age, for the diagnosis of hypolactasia.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase I, Single-Centre, Double-Blind, Randomized, Placebo-Controlled Clinical Trial
- 盲法
- Double (Subject, Investigator)
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
- •Either male of female children between 5 or 11 years of age.
- •Participant’s parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Subjects in good health with no baseline gastrointestinal condition.
- •Participants that regularly consume lactose containing products and have no signs or symptoms that could be associated with intestinal lactase deficiency (Participants will be inquire about this aspect at screening visit).
排除标准
- •Participant’s parent(s)/legal guardian(s) are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- •Participant has a known medical history of diabetes mellitus.
- •Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
- •Participant has a known history of substance abuse.
- •Participant has taken either acetylsalicylic acid or indomethacin in the 48 hours prior to study enrollment.
- •Any condition or situation precluding or interfering the compliance with the protocol.
- •Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to Gaxilose (LacTEST 0,45g) excipients.
- •Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to any of the ingredients of the on-site meals.
- •Participant has a known family history of the C/T-13910 and G/A-22018 polymorphisms associated with intestinal lactase deficiency.
- •Participant has a known medical history of decreased renal function of any cause (as defined by an estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2).
- •Participant has a known medical history of either clinical or systemic manifestation of portal hypertension (i.e., ascites, cirrhosis…).
- •Participant has a known medical history of total gastrectomy and/or vagotomy.
- •Participant has a known medical history of myxoedema.
- •Participant has a known medical history of pentosuria and/or galactosaemia.
结局指标
主要结局
PK analysis for urinary xylose excretion will be based on the following parameters: maximum urinary excretion rate detected at 0-3, 3-4 and 4-5h; its mean time during the corresponding interval (Tmax) and total xylose excreted (Ae0-5). All urine samples will be analyzed at a laboratory located in Hospital Universitario de Getafe
PK analysis for urinary xylose excretion will be based on the following parameters: maximum urinary excretion rate detected at 0-3, 3-4 and 4-5h; its mean time during the corresponding interval (Tmax) and total xylose excreted (Ae0-5). All urine samples will be analyzed at a laboratory located in Hospital Universitario de Getafe
次要结局
- The incidence of adverse events (AEs), as well as relevant and abnormal changes from baseline in laboratory test results, and changes to vital signs in the treatment arm compared to the control arm.
研究者
Carmen Hermida
Scientific
Venter Pharma S.L.
研究点 (1)
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