NCT03355170撤回4 期
Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation
Neutec Ar-Ge San ve Tic A.Ş16 个研究点 分布在 1 个国家开始时间: 2018年3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
- 撤回
- 发起方
- 试验地点
- 16
- 主要终点
- Change in QT and corrected QT (QTc) interval compared to baseline
研究概览
简要总结
The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name: Lasotab) in GERD patients in terms of cardiac safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •GERD patients with BMI 18-33 kg/m2
- •Patients with esophagitis class A-B according to Los Angeles classification
排除标准
- •Patients whose long QT syndrome risk score >
- •Patients with family history of short or long QT syndrome.
- •Patients 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 (>460 ms).
- •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.
- •Malabsorption.
- •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, sucralfate, atazanavir, theophylline, tacrolimus, fluvoxamine, rifampisin, nefazodone and aprepitant.
- •Patients taken drugs carried with P-glycoprotein, indicated for heart diseases, AIDS/HIV or infection treatment.
- •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 with hypocalcemia and hypercalcemia
- •Patients taken NSAII drugs (paracetamol may be used up to 2 gr/day).
- •Patients taken antidepressants.
- •Hypersensitivity to study drugs.
研究组 & 干预措施
Lansoprazole/Domperidone
Experimental
Patient will be administered lansoprazole/domperidone 30/30 mg capsules (brand name: Duolans) half an hour before breakfast for eight weeks according to randomisation scheme.
干预措施: Lansoprazole/Domperidone (Combination Product)
Lansoprazole
Active Comparator
Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme.
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Change in QT and corrected QT (QTc) interval compared to baseline
时间窗: 8 weeks
次要结局
- Change in upper gastrointestinal symptom severity index compared to baseline.(8 weeks)
研究者
研究点 (16)
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