跳至主要内容
临床试验/EUCTR2009-017229-20-PL
EUCTR2009-017229-20-PL进行中(未招募)不适用

Efficacy and safety of PANtoprazole in the treatment and SympTom relief in patients with gAstRoesophageal reflux disease (GERD) – PAN-STAR

KRKA-POLSKA Sp. z o.o.0 个研究点开始时间: 2009年12月29日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • – Patients of both genders at the age over 18
  • – Patients with typical GERD symptoms (heartburn/or regurgitation)
  • – Signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • – Patients with esophageal or gastric malignancies
  • – Patients with a terminal condition
  • – Patients with renal impairment (serum creatinine > 300 µmol/l)
  • – Pregnancy and breast-feeding
  • – Patients positive for Helicobacter pylori infection
  • – Patients with GERD symptoms who have been unsuccessfully treated with proton pump inhibitors during a period of 6 months prior to inclusion
  • – Patients with Barretts’ esophagus
  • – Patients with evidence of dysplasia
  • – Patients with active ulcer disease (gastric, duodenal)
  • – Patients who have been treated with a proton pump inhibitor 30 days or less prior to the first visit
  • – Hypersensitivity to pantoprazole
  • – Patients taking any medicine that should influence the results of the treatment
  • – Patients not able out of any reason to make decisions about participation in the study or not able to fulfill the requirements of the protocol

研究者

发起方
KRKA-POLSKA Sp. z o.o.

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