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.
調査の概要
研究の種類
入学
段階
- フェーズ 4
連絡先と場所
研究場所
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Antrim、イギリス、BT41 3AE
- Altana Pharma/Nycomed
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Ashford、イギリス、TW15 3RN
- Altana Pharma/Nycomed
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Aston Clinton, Aylesbury、イギリス、HP22 5LB
- Altana Pharma/Nycomed
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Atherstone, Warwick、イギリス、CV9 1EU
- Altana Pharma/Nycomed
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Bangor, Northern Ireland、イギリス、BT19 1PP
- Altana Pharma/Nycomed
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Barry、イギリス、CS62 7EB
- Altana Pharma/Nycomed
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Barry, Vale of Glamorgan, Cardiff、イギリス、CF63 4HP
- Altana Pharma/Nycomed
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Bath、イギリス、BA1 2SR
- Altana Pharma/Nycomed
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Bath、イギリス、BA2 4BY
- Altana Pharma/Nycomed
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Belfast、イギリス、BT5 7BP
- Altana Pharma/Nycomed
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Belfast、イギリス、BT7 1DA
- Altana Pharma/Nycomed
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Bexhill-on-Sea, Easr Sussex、イギリス、TN40 1JJ
- Altana Pharma/Nycomed
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Blackpool、イギリス、FY3 7EN
- Altana Pharma/Nycomed
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Bradford on Avon, Wiltshire、イギリス、BA15 1DQ
- Altana Pharma/Nycomed
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Cardiff (Wales)、イギリス、CF14 9BB
- Altana Pharma/Nycomed
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Chesterfield、イギリス、S40 1LE
- Altana Pharma/Nycomed
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Chesterfield、イギリス、S40 4TF
- Altana Pharma/Nycomed
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Chippenham、イギリス、SN15 1HP
- Altana Pharma/Nycomed
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Chippenham, Wiltshire、イギリス、SN15 2SB
- Altana Pharma/Nycomed
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Cookstown、イギリス、BT80 8BG
- Altana Pharma/Nycomed
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Crawley、イギリス、RH10 7DX
- Altana Pharma/Nycomed
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Crawley, West Sussex、イギリス、RH10 1LL
- Altana Pharma/Nycomed
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Downpatrick, Northern Ireland、イギリス、BT30 6HY
- Altana Pharma/Nycomed
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Dronfield、イギリス、S18 1RU
- Altana Pharma/Nycomed
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Ely、イギリス、CF5 4AE
- Altana Pharma/Nycomed
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Glasgow、イギリス、G45 9AW
- Altana Pharma/Nycomed
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Hull、イギリス、HU3 3BH
- Altana Pharma/Nycomed
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Kent、イギリス、CT5 1BZ
- Altana Pharma/Nycomed
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Keresely End, Coventry、イギリス、CV7 8LA
- Altana Pharma/Nycomed
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Leigh Lancs、イギリス、WN7 2RB
- Altana Pharma/Nycomed
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Leigh on Sea, Essex、イギリス、SS9 2SQ
- Altana Pharma/Nycomed
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Lisburn、イギリス、BT28 1LU
- Altana Pharma/Nycomed
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Middlesex、イギリス、HA6 2RN
- Altana Pharma/Nycomed
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New Street, Ledbury、イギリス、HR8 2DX
- Altana Pharma/Nycomed
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Sheffield、イギリス、S39DA
- Altana Pharma/Nycomed
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Sheffield、イギリス、S5 7QB
- Altana Pharma/Nycomed
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Slough, Berks、イギリス、SI2 1HD
- Altana Pharma/Nycomed
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Somerset、イギリス、BA111EZ
- Altana Pharma/Nycomed
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Southdown, Bath、イギリス、BA2 1NH
- Altana Pharma/Nycomed
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St George's Way, Sunderland、イギリス、SR2 7BW
- Altana Pharma/Nycomed
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Sunbury on Thames, Middlesex、イギリス、TW16 6RH
- Altana Pharma/Nycomed
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Trowbridge、イギリス、BA14 9AR
- Altana Pharma/Nycomed
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Trowbridge, Wilts、イギリス、BA14 7EG
- Altana Pharma/Nycomed
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Warminster Wiltshire、イギリス、BA12 9AA
- Altana Pharma/Nycomed
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Watford、イギリス、WD25 0EA
- Altana Pharma/Nycomed
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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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
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二次結果の測定
結果測定 |
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Symptom relief rates
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symptom status (compared with pre-treatment)
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time to reach first relief from reflux disease related symptoms
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time to reach sustained symptom relief
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relief rates from reflux disease related complaints
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influence of the H. pylori-status on the symptom relief rates
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安全性。
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Professor of Primary Care、Centre for Primary and Community Care, Sunderland, United Kingdom
研究記録日
主要日程の研究
研究開始
一次修了
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。