Evaluation of efficacy and safety of fixed dose combination of a proton pump inhibitor and a dopamine (DA2) antagonist in the treatment of gastroesophageal reflux disease (GERD): a randomized, open label, comparative, multicentric study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- •Nausea
研究概览
简要总结
Thisstudy is a randomized, open label, parallel group, multi-centre study comparingthe safety and efficacy of Fixed dose combination of a proton pump inhibitor anda prokinetic drug versus same proton pump inhibitor in GERD. Dosing schedule of fixed dose combination capsuleis once daily before breakfast for 4 weeks and comparator drug (proton pumpinhibitor) tablet is once daily before breakfast for 4 weeks in 200 patientswith Gastro esophageal reflux disease that will be conducted in nine centers inIndia. The primary outcome measure will be average change from baseline to endof study on symptom of heart burn, epigastric pain and nausea. The secondaryoutcome will be average change form baseline to end of study on symptoms ofDysphagia, Chest pain, Dry cough. Evaluation of Clinical global impression onseverity (CGI-S) will be done on baseline visit and end of study. Evaluation ofClinical global impression on improvement will be done on week 2 (Visit 2) andend of study. Evaluation of Adverse event/s will be assessed on every visit. This is not a globalstudy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients aged between 18-70 years.
- •2.Patients with GERD (Gastro esophageal Reflux Disease).
- •3.Patients willing to give informed consent.
排除标准
- •1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2.Patients with peptic ulcer or Zollinger-Ellison syndrome.
- •3.Patients with previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
- •4.Patients with other diseases or conditions such as scleroderma, pancreatitis, cancer, Parkinson’s disease, epilepsy, mania and inflammatory bowel disease.
- •5.Patients with any severe illnesses (hepatic, renal, cardiac).
- •6.Patients with uncontrolled diabetes, hypertension, clotting disorder.
- •7.History of heavy smoking (> 20 cigarettes per day).
- •8.Hypersensitive to either esomeprazole or levosulpiride.
- •9.Recent (in the past two years) drug dependence or abuse.
- •10.History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.
结局指标
主要结局
•Nausea
时间窗: Baseline Visit (day 0), week 2 & week 4.
Average change from baseline to end of study of following symptoms by Likert scale:
时间窗: Baseline Visit (day 0), week 2 & week 4.
•Heart burn
时间窗: Baseline Visit (day 0), week 2 & week 4.
•Epigastric Pain
时间窗: Baseline Visit (day 0), week 2 & week 4.
次要结局
- 1.Average change from baseline to end of study of following symptoms evaluated by ‘Present (0)’ or ‘Absent (1)’:(•Dysphagia)