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临床试验/NCT00261339
NCT00261339已完成4 期

PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD

Takeda46 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年8月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
300
试验地点
46
主要终点
GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks of treatment

研究概览

简要总结

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. Proton pump inhibitors such as pantoprazole, can relieve symptoms of GERD in a large proportion of patients.

Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response to treatment. Therefore, a questionnaire was developed to assess GERD symptoms ('ReQuest TradeMark in Practice'). An important point to consider when using such a questionnaire is to follow the patients´ medical response to treatment and note whether a patient needs to change dosing, such as changing from full dose to half dose, or vice versa.

The aim of the study is to determine the value of the questionnaire ('ReQuest TradeMark in Practice') according to treating physicians' clinical judgment when using pantoprazole at full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and two treatment period (8 weeks each). During the first treatment period, pantoprazole will be administered once daily at full dose (40 mg). During the second treatment period, pantoprazole will be administered once daily at half dose (20 mg). The study will provide further data on safety and tolerability of pantoprazole.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Main inclusion criteria:
  • Written informed consent
  • Outpatients of at least 18 years of age
  • Patients with symptoms of GERD

排除标准

  • Signs, indicating other gastrointestinal diseases
  • Other concomitant diseases
  • Special restrictions for female patients
  • Previous medication
  • Concomitant medication

结局指标

主要结局

GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks of treatment

次要结局

  • Symptom relief rates
  • symptom status (compared with pre-treatment)
  • time to reach first relief from reflux disease related symptoms
  • time to reach sustained symptom relief
  • relief rates from reflux disease related complaints
  • influence of the H. pylori-status on the symptom relief rates
  • safety.

研究者

发起方
Takeda
申办方类型
Industry

研究点 (46)

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