NCT01145339已完成3 期
A Phase III, Non-Inferiority, Randomized, Double-Blind, Parallel-Group, Multicentre, Single-Dose, Comparative Clinical Study of Lactase Eurofarma (Test Drug) and Lactaid® (Comparative Drug), Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance (Hypolactasia)
Eurofarma Laboratorios S.A.7 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 7
- 主要终点
- Hydrogen value in the air expired
研究概览
简要总结
The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient should be a male or female, aged between 18 and 60 years old;
- •Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;
- •The female patients should agree to use birth control methods during the study participation;
- •To be able to meet the study instructions and all the visits required;
- •To give a free consent to participate in the study and sign the informed consent form (ICF).
排除标准
- •Secondary hypolactasia;
- •Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;
- •Colonoscopy or colon cleaning procedure 4 weeks before the start of study
- •Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;
- •Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.
- •Diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure),
- •Hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study;
- •Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF;
- •Pregnancy or lactation;
- •Use of alcohol, exceeding 3 doses daily;
- •Participation in another clinical study on the last 12 months;
- •Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).
研究组 & 干预措施
Lactase EUF
Experimental
1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g).
干预措施: Lactase (Drug)
Lactase Ref
Active Comparator
1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g).
干预措施: Lactase (Drug)
结局指标
主要结局
Hydrogen value in the air expired
时间窗: 03 times
Hydrogen value in the expired air for 3h after the patient exposure to the standardized Lactose 25g dose with interventional exogenous Lactase (comparative and test drugs).
次要结局
未报告次要终点
研究者
研究点 (7)
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