Evaluation of efficacy and safety of fixed dose combination of a proton pump inhibitor 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
- 尚未招募
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Average change from baseline to end of study of following symptoms by Likert scale:
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 meal for 4 weeks and comparator drug (proton pumpinhibitor) tablet is once daily in the morning or before breakfast for 4 weeksin 200 patients with Gastro esophageal reflux disease that will be conducted ineight centers in India. The primary outcome measure will be averagechange from baseline to end of study on symptom of heart burn, epigastric painand nausea. The secondary outcome will be average change form baseline to endof study on symptoms of Dysphagia, Chest pain, Dry cough. Evaluation ofClinical global impression on severity (CGI-S) will be done on baseline visitand end of study week 4 (Visit 3). Evaluation of Clinical global impression onimprovement will be done on week 2 (Visit 2) and end of study week 4 (Visit 3).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 Pantoprazole 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
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.
•Nausea
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)