CTRI/2012/02/002406招募中3 期
A Multicentric, Randomized, Open Label, Parallel-group, Comparative Clinical trial to evaluate the Safety and Efficacy of the Fixed-dose combination of Esomeprazole Magnesium 40 mg DR and Levosulpiride ER 75 mg Capsule versus Esomeprazole Magnesium 40 mg DR tablet in patients with Gastroesophageal Reflux Disease
Torrent Pharmaceuticals Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 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
- •?Newly diagnosed GERD patients having non-erosive or erosive GERD with heartburn and acid regurgitation as the predominant symptoms and episode of heart burn and acid regurgitation occurring on at least 2 days during the last 7 days prior to inclusion.
- •?Adult males or females, age 18 years.
- •?All subjects who are willing to give informed consent.
- •?All subjects who are willing adhere to protocol requirements.
排除标准
- •?History or presence of upper gastrointestinal anatomic or motor disorders.
- •?Acute peptic ulcer and/or ulcer complications.
- •?Bleeding disorder or History of hematemesis within last 2 months.
- •?Barret?s esophagus or dysplastic changes in esophagus
- •?Intake of Glucocortocoids or NSAIDS for more than three consecutive day/week during last month.
- •?Intake of PPI, H2 blocker or prokinetic for more than 3 consecutive days in previous 7 days.
- •?History of atrophic gastritis or gastric malignancy or other GI malignancy.
- •?Any major cardiovascular, pulmonary, hematologic, hepatic, renal, metabolic, gastrointestinal or endocrine disorder.
- •?Any major surgery in previous 1 month.
- •?History of Pheochromocytoma, epilepsy, mania, breast diseases
- •?History of drug or medication abuse within the past year, or current alcohol abuse.
- •?Previous participation in any esomeprazole magnesium or levosulpiride clinical trial within last 1 month.
- •?Hypersensitivity to PPI or levosulpiride
- •?Subjects with serum ALT, AST, of 2.5 X ULN and S.Bilirubin 1.5 X ULN
- •?Subject with serum creatinine ULN
- •?Women with positive urine pregnancy test.
- •?Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
研究者
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