CTRI/2012/04/002575尚未招募3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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, Parkinsonâ??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.
研究者
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