NCT02636413已完成4 期
Evaluation of the Impact of LacTEST on Diagnostic Thinking and on Patient Management, and of the Reproducibility (Test-Retest), for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
VenterPharma6 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 6
- 主要终点
- Visual Analogical Scale
研究概览
简要总结
The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking and on patient management, and its reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of either sex, between 18 and 70 years old.
- •Capacity for understanding and giving the informed consent to participate in this study.
- •Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the gaxilose summary of product characteristics (SmPC).
排除标准
- •Pregnant women or breast-feeding women.
- •Unable or reticent to give the informed consent or to comply with the study requirements.
- •Patients with glomerular filtration rate (GFR) less than 90 ml/min/1.73m
- •Portal hypertension: ascites, cirrhosis.
- •Medical records of total gastrectomy and/or vagotomy.
- •Patients diagnosed with myxedema.
- •Patients with Diabetes Mellitus.
- •Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
- •Patients who are drug abuse consumers.
- •Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
- •Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
- •Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.
研究组 & 干预措施
LacTEST
Experimental
0,45 g of gaxilose po, once, per diagnostic test performed.
干预措施: gaxilose (Drug)
Hydrogen Breath Test
Active Comparator
25 to 50 g of lactose po, once, per diagnostic test performed.
干预措施: lactose (Dietary Supplement)
结局指标
主要结局
Visual Analogical Scale
时间窗: Through study completion, up to 10 months.
The primary objective is to demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT) using a validated method (VAS results pre and post-test), on the impact on diagnostic thinking for the diagnosis of hypolactasia.
次要结局
- Physician's Questionnaire(Through study completion, up to 10 months.)
- Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.(Through study completion, up to 10 months.)
- Intraclass Correlation Coefficient(Through study completion, up to 10 months.)
研究者
研究点 (6)
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