NCT03037606已完成4 期
Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets 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 48 人开始时间: 2017年8月1日最近更新:
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
- 48
- 试验地点
- 1
- 主要终点
- AUC of 24-hour intragastric pH >4 compared to baseline
研究概览
简要总结
It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD).
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
- Double (Participant, Investigator)
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) 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
- •Patiets with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
- •Patients whose Hiatus hernia is > 3 cm.
- •Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.
- •Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (>450 ms for male, >470 ms for female patients).
- •Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
- •Patients with major psychiatric disease.
- •Alcoholism and drug use.
- •Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.
- •Malabsorbtion.
- •Immunosuppressive patients.
- •Patients taken cortisone.
- •Patients taken other drugs that prolong QT interval.
- •Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents, prostaglandin analogues, sukralfat.
- •Pregnancy or breast-feeding.
- •Patients taken drugs that may affect gastrointestinal system motility or acid release.
- •History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).
- •Patients taken NSAII drugs (paracetemol may be used up to 2 gr/day).
- •Patients taken antidepressants.
- •Hypersensitivty to study drugs.
- •Known allergy to peanut and soy.
研究组 & 干预措施
Rabelis DDR 50 mg Capsules and 1 placebo tablet
Experimental
Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.
干预措施: Rabelis DDR 50 mg Capsules (Drug)
Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule
Active Comparator
Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.
干预措施: Pariet 20 mg Enteric Coated Tablets (Drug)
结局指标
主要结局
AUC of 24-hour intragastric pH >4 compared to baseline
时间窗: 7 days
Percentage time of 24-hour intragastric pH >4 compared to baseline
时间窗: 7 days
次要结局
- Percentage time of 24-hour intragastric pH >2 compared to baseline(7 days)
- Percentage time of 24-hour intragastric pH >6 compared to baseline(7 days)
- Significant increase in total measurements of median pH(7 days)
- Significant increase in nocturnal measurements of median pH(7 days)
- Decrease in reflux symptom index calculated by weekly regurgitation numbers(7 days)
- Decrease in reflux symptom index calculated by weekly pyrosis numbers(7 days)
- AUC of 24-hour intragastric pH >2 compared to baseline(7 days)
- AUC of 24-hour intragastric pH >6 compared to baseline(7 days)
- Percentage time of 24-hour total intragastric pH >4 compared to baseline(7 days)
- AUC of 24-hour total intragastric pH >4 compared to baseline(7 days)
- Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline(7 days)
- AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am 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 Treatments)(7 days)
- Change in QT interval obtained by ECG compared to baseline(21 days)
研究者
研究点 (1)
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