CTRI/2013/12/004261已完成4 期
Randomized controlled study of the effectiveness of lafutidine versus pantoprazole for uninvestigated dyspepsia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
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
- •Symptoms of dyspepsia for at least 1 months
- •Moderate-to severe symptoms (score >= 4 on the7-point Likert scale for each symptom in global overall symptoms scale).
排除标准
- •Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia),
- •History of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrettâ??s esophagus)
- •Patients with angina pectoris.
- •Patients who show any of the following values at the baseline laboratory tests: Hemoglobin < 9.5 g/dL, total leukocyte count < 3,000/mm3, platelet count < 75,000/mm3, AST and ALT >= 100 IU/L, Creatinine >= 1.5 mg/dl
- •Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment
- •Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs.
- •Women who are pregnant, lactating, or not willing to use adequate methods of contraception.
- •History of substance abuse.
- •Any other condition which can lead the investigators to consider the subject unsuitable for selection.
研究者
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