NCT02958046已完成4 期
Phase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
Neutec Ar-Ge San ve Tic A.Ş1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年1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
- 12
- 试验地点
- 1
- 主要终点
- The AUC of 24-hour intragastric pH >4 compared to baseline
研究概览
简要总结
The purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).
详细描述
Objectives of the trial to assess the efficacy of lansoprazole in combination with domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics and gastric emptying in patients with GERD.
24 hour pH measurement and gastric emptying test will be done at screening visit and after 7 days of drug treatment. Twelve patients will take one tablet for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) during last one year with at least 1 or more episodes a week
- •Age ≥ 18 years and <65 years
- •Helicobacter pylori (an infection) negative
- •Have a body mass index (BMI) between 18 and 33 kg/m²
- •pH>4 gastric exposure <25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
- •Pathologic intraesophageal acidity exposure (DeMeester score >14.75 and/or >4% of pH<4 (at least 21 hours measured)
排除标准
- •Have food existence at stomach during upper GIS endoscopy, Barrett's stricture, GIS bleeding, malignite, and all type of GIS pathology to affects the study
- •Have allergy to the study drug or any of the excipients of the formulation
- •Must use of pain relieving medications (NSAIDs) during study, (paracetamol not excess of 2 gram/day can be used)
- •Use of any concomitant therapy which are drug affects the motility of GIS and acid secretion
- •Use of prostaglandin analogs and sucralfate
- •Have taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study
- •History of surgery of cholecystectomy
- •Abusing drugs or alcohol
- •Have a major psychiatric disease
- •Use of antidepressant (patient with minor depression or under controlled with drug can be included)
- •Have suppressed immune system or taken a immunosupressive treatment, including cortisone.
- •Have malabsorption, gastric outlet obstruction that affects the absorption of drug
- •Must use of drug ketoconazole, iron salts, digoxin, ampicilin esters , anticoagulants, antineoplastic agents
- •Women who are pregnant or of childbearing
- •Have gastroparesis
- •Current or a history of cancer, with the exception of fully excised skin carcinoma (Malign Melanoma will be excluded).
- •Have severe concomitant disease (i.e. uncontrolled or insuline dependent diabetes mellitus, symptomatic bladder stone (patients have asemptomatic, not undergone colesistit, stone <3cm and polib <1cm can be included), active or unhealed gastric or duodenum ulcer, Zollinger Ellison syndrome, primary esophageal motility disorder, pancreatitis, inflammatory bowel disease, chronic hepatic disease, severe lung disease, uncontrolled kidney failure, cardiac failure, cerebrovascular disease, epilepsy) which affects the conduct and result of study.
研究组 & 干预措施
Lansoprazole/Domperidone
Experimental
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
干预措施: Lansoprazole/Domperidone (Drug)
结局指标
主要结局
The AUC of 24-hour intragastric pH >4 compared to baseline
时间窗: 7 days
The percentage time of 24-hour intragastric pH >4 compared to baseline
时间窗: 7 days
次要结局
- The percentage time of 24-hour intragastric pH >2 compared to baseline(7 days)
- The significant increase in nocturnal measurements of median pH(7 days)
- The significant increase in total measurements of median pH(7 days)
- The decrease in reflux symptom index calculated by weekly regurgitation numbers(7 days)
- The decrease in reflux symptom index calculated by weekly pyrosis numbers(7 days)
- The percentage time of 24-hour intragastric pH >6 compared to baseline(7 days)
- The AUC of 24-hour intragastric pH >2 compared to baseline(7 days)
- The AUC of 24-hour intragastric pH >6 compared to baseline(7 days)
- The percentage time of 24-hour total intragastric pH >4 compared to baseline(7 days)
- The AUC of 24-hour total intragastric pH >4 compared to baseline(7 days)
- The evaluation of gastric emptying by octanoic acid breath test compared to baseline(7 days)
- The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment)(7 days)
研究者
研究点 (1)
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