PER-028-06已完成未知
A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAK-390MR (60MG QD AND 90MG QD) AND AN ACTIVE COMPARATOR, LANSOPRAZOLE (30MG QD) IN THE CURE OF EROSIVE ESOPHAGITIS
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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. Before any specific procedure of the study is performed, the patient will voluntarily sign an Informed Consent Form (ICF).
- •2. Male or female patients with at least 18 years of age.
- •3. All patients must have a negative serum pregnancy test in the Selection and a negative urine pregnancy test on Day -1 and be using and agree to continue using a double-barrier method of contraception.
- •4. Patients should have endoscopically confirmed ES.
排除标准
- •1. The patients seropositive for H. pylori. However, patients who are seropositive and have received therapeutically approved eradication treatment within the last 6 months will have the right to participate.
- •2. Use of proton pump inhibitors (PPIs) prescribed or not prescribed during the 14 days before the selection endoscopy and throughout the study.
- •3. Use of histamine (H2) antagonist receptors or sucralfate prescribed or not prescribed during the 7 days before the endoscopy of Selection and throughout the study.
- •4. Use of antacids during the Selection and Treatment Periods.
- •5. Patients who use medications with important anticholinergic effects.
- •6. Patients who can not stop using the following medications: a) Misoprostol. b) Prokinetics.
- •7. Need continuous anticoagulant treatment.
- •8. Use of any investigational medication within 30 days of the Selection.
- •9. Cancer within the previous 3 years.
- •10. Any condition that may require surgery during the course of the study.
- •11. Barrett´s esophagus and / or dysplastic changes endoscopically confirmed in the esophagus.
- •12. Patients with a history of dilatation due to esophageal stenosis, different from Schatzki´s ring.
- •13. Patients with active gastric or duodenal ulcers within 4 weeks of the first dose of the study medication.
- •14. Concomitant diseases that affect the esophagus, history of treatment with radiation or cryotherapy in the esophagus, caustic or physicochemical trauma such as sclerotherapy for the esophagus.
- •15. Evidence of uncontrolled systemic disease.
- •16. Patients with abnormal laboratory values that suggest a clinically important underlying disease or condition.
- •17. Patient known as a carrier of acquired immunodeficiency syndrome (AIDS).
- •18. Current or previous evidence of Zollinger-Ellison syndrome or another hypersecretory condition.
- •19. History of gastric, duodenal or esophageal surgery except simple suture of an ulcer.
- •20. Acute upper gastrointestinal bleeding within 4 weeks of selection endoscopy.
- •21. Patients who have received blood products within 3 months prior to the first dose of the study medication.
- •22. Known hypersensitivity to any PPI, any component of TAK-390MR, or Gelusil / antacid.
- •23. Women who are pregnant or breastfeeding.
- •24. History of alcohol abuse or illegal use of drugs or drug addiction in the 12 months prior to the Selection.
- •25. Patients who can not meet the requirements of the study or are not suitable for some reason.
研究者
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