Determination of a Questionnaire After Treatment With Pantoprazole at Full Dose and Half Dose in Adult Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/UK-506)
PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
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.
研究概览
研究类型
注册
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Antrim、英国、BT41 3AE
- Altana Pharma/Nycomed
-
Ashford、英国、TW15 3RN
- Altana Pharma/Nycomed
-
Aston Clinton, Aylesbury、英国、HP22 5LB
- Altana Pharma/Nycomed
-
Atherstone, Warwick、英国、CV9 1EU
- Altana Pharma/Nycomed
-
Bangor, Northern Ireland、英国、BT19 1PP
- Altana Pharma/Nycomed
-
Barry、英国、CS62 7EB
- Altana Pharma/Nycomed
-
Barry, Vale of Glamorgan, Cardiff、英国、CF63 4HP
- Altana Pharma/Nycomed
-
Bath、英国、BA1 2SR
- Altana Pharma/Nycomed
-
Bath、英国、BA2 4BY
- Altana Pharma/Nycomed
-
Belfast、英国、BT5 7BP
- Altana Pharma/Nycomed
-
Belfast、英国、BT7 1DA
- Altana Pharma/Nycomed
-
Bexhill-on-Sea, Easr Sussex、英国、TN40 1JJ
- Altana Pharma/Nycomed
-
Blackpool、英国、FY3 7EN
- Altana Pharma/Nycomed
-
Bradford on Avon, Wiltshire、英国、BA15 1DQ
- Altana Pharma/Nycomed
-
Cardiff (Wales)、英国、CF14 9BB
- Altana Pharma/Nycomed
-
Chesterfield、英国、S40 1LE
- Altana Pharma/Nycomed
-
Chesterfield、英国、S40 4TF
- Altana Pharma/Nycomed
-
Chippenham、英国、SN15 1HP
- Altana Pharma/Nycomed
-
Chippenham, Wiltshire、英国、SN15 2SB
- Altana Pharma/Nycomed
-
Cookstown、英国、BT80 8BG
- Altana Pharma/Nycomed
-
Crawley、英国、RH10 7DX
- Altana Pharma/Nycomed
-
Crawley, West Sussex、英国、RH10 1LL
- Altana Pharma/Nycomed
-
Downpatrick, Northern Ireland、英国、BT30 6HY
- Altana Pharma/Nycomed
-
Dronfield、英国、S18 1RU
- Altana Pharma/Nycomed
-
Ely、英国、CF5 4AE
- Altana Pharma/Nycomed
-
Glasgow、英国、G45 9AW
- Altana Pharma/Nycomed
-
Hull、英国、HU3 3BH
- Altana Pharma/Nycomed
-
Kent、英国、CT5 1BZ
- Altana Pharma/Nycomed
-
Keresely End, Coventry、英国、CV7 8LA
- Altana Pharma/Nycomed
-
Leigh Lancs、英国、WN7 2RB
- Altana Pharma/Nycomed
-
Leigh on Sea, Essex、英国、SS9 2SQ
- Altana Pharma/Nycomed
-
Lisburn、英国、BT28 1LU
- Altana Pharma/Nycomed
-
Middlesex、英国、HA6 2RN
- Altana Pharma/Nycomed
-
New Street, Ledbury、英国、HR8 2DX
- Altana Pharma/Nycomed
-
Sheffield、英国、S39DA
- Altana Pharma/Nycomed
-
Sheffield、英国、S5 7QB
- Altana Pharma/Nycomed
-
Slough, Berks、英国、SI2 1HD
- Altana Pharma/Nycomed
-
Somerset、英国、BA111EZ
- Altana Pharma/Nycomed
-
Southdown, Bath、英国、BA2 1NH
- Altana Pharma/Nycomed
-
St George's Way, Sunderland、英国、SR2 7BW
- Altana Pharma/Nycomed
-
Sunbury on Thames, Middlesex、英国、TW16 6RH
- Altana Pharma/Nycomed
-
Trowbridge、英国、BA14 9AR
- Altana Pharma/Nycomed
-
Trowbridge, Wilts、英国、BA14 7EG
- Altana Pharma/Nycomed
-
Warminster Wiltshire、英国、BA12 9AA
- Altana Pharma/Nycomed
-
Watford、英国、WD25 0EA
- Altana Pharma/Nycomed
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Main inclusion criteria:
- Written informed consent
- Outpatients of at least 18 years of age
- GERD
- Patients with symptoms of GERD
Main exclusion criteria:
- Signs, indicating other gastrointestinal diseases
- Other concomitant diseases
- Special restrictions for female patients
- Previous medication
- Concomitant medication
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
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
|
次要结果测量
结果测量 |
|---|
|
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
|
|
安全。
|
合作者和调查者
赞助
调查人员
- 首席研究员：Professor of Primary Care、Centre for Primary and Community Care, Sunderland, United Kingdom
研究记录日期
研究主要日期
学习开始
初级完成
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.